Senior Inspector, Receiving - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Senior Inspector, Receiving in Irvine, CA who possesses:
High school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessment5+ years of quality inspection experience with exposure to receiving inspection activitiesWorking knowledge of Geometric Dimensioning and TolerancingExperience within an ISO 13485 environment highly preferredFULL DESCRIPTION: We are seeking a Senior Inspector, Receiving to perform receiving inspections on incoming materials in a highly regulated medical device environment. This permanent role is responsible for mechanical, visual, and functional inspection of materials, inspection record maintenance, NCR initiation, documentation review, supplier quality support, and collaboration with Engineering and Supplier Management teams. The ideal candidate will have strong quality inspection experience, receiving inspection exposure, GD&T knowledge, GDP documentation skills, and the ability to inspect a wide variety of components accurately in a fast-paced environment.
The selected candidate will be responsible for:
Performing receiving inspection tasks for incoming materialsCompleting mechanical, visual, and functional inspection of materialsUsing measuring devices and testing equipment to assess product qualityInspecting a variety of components, including plastic, injection molded, metal, catheter, and related medical device componentsReviewing and interpreting engineering drawings and specificationsUsing inspection tools such as calipers, micrometers, height gauges, pin gauges, laser micrometers, vision systems, and similar inspection equipmentMaintaining and filing inspection reports and recordsMaintaining the inspection area in a clean and orderly fashionComplying with quality management system policies and proceduresInitiating Non-Conformance RecordsAssisting with material containment, root cause investigations, and corrective actionsPartnering with engineers and supplier management personnel to resolve issues, nonconformances, and CAPA items as applicableParticipating in special projects, including test method validations, protocols, and first article inspectionsSupporting the training of other inspectors through work demonstration and feedbackPrioritizing inspections based on business needsParticipating in or leading process improvement initiatives within the inspection areaCompleting inspection documentation accurately and in accordance with GDP requirementsSupporting fast-paced inspection needs while maintaining accurate paper-based recordsCollaborating with cross-functional teams as neededMaintaining reliable and consistent attendance to support production operationsWorking full scheduled shifts and overtime as required to meet operational and production needsPerforming other duties as assigned
The selected candidate will also possess:
5+ years of quality inspection experience requiredReceiving inspection experience requiredMedical device quality inspection experience preferredAerospace quality inspection experience may be consideredExperience working within a quality management system in a highly regulated industry requiredISO 13485 experience highly preferredWorking knowledge of Geometric Dimensioning and Tolerancing requiredAbility to read and interpret engineering drawings and specifications requiredExperience inspecting different component types, including plastic, injection molded, metal, catheter, and visually inspected components, preferredProficiency using basic inspection tools such as calipers, micrometers, height gauges, and pin gauges requiredExperience with laser micrometers, vision measurement systems, Keyence, or similar inspection equipment preferredStrong background in Good Documentation Practices requiredExperience maintaining handwritten or paper-based inspection records preferredStrong documentation skillsAbility to assess certificates, records, and documentation for compliance preferredAbility to understand sample sizes, tolerances, and appropriate tool selection based on drawing requirementsAbility to work effectively and collaborate with cross-functional teamsAbility to articulate results and conclusions verbally and in writing to technical and non-technical personnelAbility to take initiative and conduct hands-on workAbility to work independently after trainingAbility to handle multiple tasks with high attention to detailBroad knowledge of operational systems and practicesAbility to continuously expand proficiency in inspection techniquesStrong hand-eye coordination and high manual dexterityMotivated, willing to learn, and able to ask questions when neededAbility to work in a fast-paced and changing environmentHigh school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessmentAbility to work onsite in Irvine, CAAbility to work 2nd shift from 2:30 PM to 11:00 PMAbility to train on 1st shift from approximately 6:00 AM to 2:30 PM for the first 2 to 3 months, or as neededAbility to work overtime as required based on production needsAbility to support a permanent opportunityNo sponsorship available
Physical Requirements:
Ability to work in a corporate office, laboratory, warehouse, and controlled cleanroom environment as neededAbility to work in a controlled cleanroom environment while wearing full cleanroom gowning, including gown or coveralls, gloves, mask, hairnet, boot covers, and other PPE as neededAbility to stand for extended periods during the work shiftAbility to stand, walk, and sit for prolonged periods of timeAbility to perform tasks requiring close visual acuity and strong attention to detailAbility to use hands and fingers to manipulate small tools and componentsAbility to use inspection tools, measuring devices, and testing equipment as part of routine job dutiesAbility to inspect components ranging from very small parts to larger parts or tubing as neededAbility to lift or move materials weighing up to 25 poundsAbility to push, pull, twist, climb, balance, stoop, kneel, and crawl as neededAbility to perform repetitive motions, including reaching and graspingAbility to follow strict safety, contamination control, quality, laboratory, and cleanroom protocols
Salary Range: $28 to $34/hour plus 5% bonus potential
More information can be found at www.simplybiotech.com.
Senior Inspector, Quality Control (THV) - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Senior Inspector, Quality Control (THV) in Irvine, CA who possesses:
High school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessment3+ years of quality experience within the medical device industryFamiliarity with 21 CFR 820 and ISO 13485 requirementsAbility to stand for long periods of time
FULL DESCRIPTION: We are seeking a Senior Inspector, Quality Control to support quality control activities related to THV manufacturing in a controlled cleanroom environment. This permanent role is responsible for functional inspection, visual inspection, final inspection, packaging inspection, documentation review, DHR review, release support, discrepancy identification, cross-functional communication, and quality system compliance. The ideal candidate will have quality inspection experience within the medical device industry, strong documentation skills, familiarity with 21 CFR 820 and ISO 13485, and the ability to support inspection activities in a fast-paced cleanroom manufacturing environment.
The selected candidate will be responsible for:
Performing quality control inspection activities related to THV manufacturingPerforming functional inspection, visual inspection, final inspection, packaging inspection, and final release activitiesCompleting assigned inspection tasks accurately and efficiently in alignment with production schedulesReviewing in-process and finished product documentationReviewing manufactured valve DHRs, preparation records, inspection records, and ancillary logs for completeness and accuracySupporting review and release activities for THV Device History Records and final product release documentationIdentifying, documenting, and communicating inspection discrepancies, documentation errors, nonconforming material, and quality concernsCommunicating issues to QC supervision, Quality Engineering, Manufacturing, and other applicable teamsSupporting Material Review Board activities by providing inspection results, documentation review input, and product status informationPerforming inspection-related activities in support of Engineering, R&D, validation, process development, and special projectsAssisting with training, onboarding, and qualification of QC InspectorsProviding hands-on guidance, procedure walkthroughs, inspection technique support, and feedback as appropriateMaintaining certification and qualification for applicable QC inspection activitiesSupporting adherence to GMP, GDP, document control, record retention, and Quality Management System proceduresVerifying that inspection equipment, tools, fixtures, and work areas are ready for use and properly maintainedEnsuring inspection equipment is within calibration or preventive maintenance requirements prior to useSupporting preventive maintenance and calibration coordination for QC equipment and inspection/test systemsProviding clear and timely communication to QC supervision and cross-functional stakeholdersCommunicating inspection status, documentation issues, product holds, release status, training needs, and quality concernsServing as a technical resource for QC inspection processesDemonstrating strong procedural knowledge, attention to detail, and consistent application of acceptance criteriaEnsuring compliance with site Health & Safety requirementsSupporting broader business and departmental objectives as neededPerforming other duties as assigned
The selected candidate will also possess:
3+ years of quality experience within the medical device industry requiredMedical device or pharmaceutical quality experience requiredHeart valve, tissue, catheter, structural heart, or THV inspection experience strongly preferredExperience with first inspection, in-process inspection, final inspection, visual inspection, functional inspection, and packaging inspection preferredExperience assessing products for compliance and final release requiredFamiliarity with 21 CFR 820 and ISO 13485 requirements requiredHands-on experience with 21 CFR 820 and ISO 13485 preferredGMP and GDP documentation experience requiredDHR review experience preferredExperience working in a controlled cleanroom environment preferredExperience using inspection tools, fixtures, equipment, or test systems preferredExperience working under microscopes, lamps, or close visual inspection conditions preferredHigh school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessmentStrong attention to detailStrong documentation skillsAbility to file and organize records in a compliant and easily retrievable mannerAbility to articulate results and conclusions verbally and in writingAbility to work effectively with cross-functional teamsAbility to communicate professionally with Quality, Manufacturing, Engineering, R&D, and related departmentsAbility to handle multiple tasks and prioritize workloadAbility to take initiative and work autonomouslyAbility to read, comprehend, and speak EnglishProficiency with Microsoft Office, including Word, Excel, and PowerPointBasic Excel skills requiredAbility to maintain reliable and consistent attendanceAbility to work onsite in Irvine, CAAbility to work 2nd shift from 2:30 PM to 11:30 PM after trainingAbility to train on 1st shift from approximately 5:30 AM to 2:30 PM for the first 3 to 6 monthsAbility to work overtime as required, including possible SaturdaysAbility to support a permanent opportunity
Physical Requirements:
Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning, including gown or coveralls, gloves, mask, hairnet, boot covers, and other PPE as neededAbility to stand and sit for prolonged periods to support inspection, testing, documentation, and review activitiesAbility to follow cleanroom, laboratory, and site safety protocols at all timesAbility to use inspection and testing equipment as part of routine job dutiesAbility to perform work requiring close visual attention and detailed product inspectionAbility to work under a microscope, inspection lamp, or similar visual inspection conditions as neededAbility to push, pull, twist, climb, balance, stoop, kneel, and crawl as neededAbility to perform repetitive motions, including reaching and graspingAbility to lift or move materials up to 25 poundsAbility to push or move carts up to 20 to 30 pounds as neededAbility to work in an active manufacturing and cleanroom environment while following GMP, GDP, quality, and safety procedures
Salary Range: $24 to $31/hour
More information can be found at www.simplybiotech.com.
Warehouse Kitting Technician - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Warehouse Kitting Technician in Vista, CA who possesses:
1 to 2 years of warehouse experienceFamiliarity with work ordersExperience working with an ERP system
FULL DESCRIPTION: We are seeking a Warehouse Kitting Technician to support outbound specimen collection kit assembly in a fast-paced warehouse and laboratory-adjacent environment. This temp-to-hire role is responsible for assembling collection kits according to incoming orders, verifying order accuracy, preparing shipping and return labels, packaging materials according to standards, and maintaining a clean and organized work area. The ideal candidate will have warehouse experience, strong attention to detail, familiarity with work orders, ERP system experience, and the ability to work with urgency and accuracy in a small team environment.
The selected candidate will be responsible for:
Assembling outbound specimen collection kits according to customer ordersReviewing incoming kit orders and verifying order details for accuracyVerifying the accuracy and quantity of all items for each orderUsing UPS and FedEx shipping software to generate required shipping and return labelsLabeling and packaging orders for shipment according to established standardsFollowing DOT and IATA shipping requirements as applicablePreparing materials for outbound kits, including boxes, tubes, ice packs, labels, return envelopes, and related kit componentsPacking orders accurately to ensure client sites receive the correct materials on timeReviewing orders, outbound labels, and return labels for accuracyPerforming quality checks of returned specimen collection kits to determine reusabilityMaintaining a clean and organized warehouse and laboratory environmentPrepping materials during downtime, including folding and assembling boxes and bundling suppliesCleaning and organizing the warehouse area as neededSupporting trash removal from laboratory-adjacent areas as neededFollowing established processes and safety proceduresCommunicating with managers and internal personnel as neededWorking with urgency, consistency, and attention to detailPerforming other duties as assigned
The selected candidate will also possess:
High school diploma or GED required1 to 2 years of warehouse experience requiredFamiliarity with work orders requiredExperience working with an ERP system requiredExperience using UPS, FedEx, or other shipping software preferredIATA/DOT certification or familiarity preferredStrong attention to detail requiredStrong organizational skillsCollaborative team mindsetAbility to thrive in a fast-paced environmentAbility to follow established processes and work instructionsAbility to communicate effectively with managers and internal personnelAbility to work independently without heavy micromanagementAbility to take initiative and stay productive during downtimeAbility to work assigned schedule with flexibility to modify as neededAbility to work onsite in Vista, CAAbility to work Monday through Friday from 8:00 AM to 5:00 PMAbility to support a temp-to-hire opportunity
Physical Requirements:
Ability to regularly sit, walk, stand, talk, and hear throughout the workdayAbility to occasionally lift and/or move up to 25 poundsAbility to use close vision, adjust focus, and view computer monitors for extended periodsAbility to use hands and fingers for assembling kits, labeling, packaging, scanning, typing, and handling warehouse materialsAbility to perform repetitive movements related to kit assembly, packaging, labeling, sorting, folding boxes, bundling supplies, and preparing shipmentsAbility to work in a standard warehouse environment with periods of time in laboratory areasAbility to interact with laboratory equipment, samples, supplies, and laboratory personnel while following appropriate safety precautionsAbility to work in an environment with moderate noise levelsAbility to maintain a clean, organized, and safe warehouse and laboratory-adjacent work areaAbility to wear required personal protective equipment as needed
Salary Range: $18 to $20/hour
More information can be found at www.simplybiotech.com.
Quality Inspector 2nd shift - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Quality Inspector 2nd shift in Santa Fe Springs, CA who possess:
Quality Inspection in Manufacturing - 2+ yrs.Blueprint Reading and/or Drawings ExperienceDimensional Inspection Tools (Micrometers/Calipers/Etc.)Computer Literate
FULL DESCRIPTION: Responsible for inspecting and testing furnished, work-in-progress, and finished goods/products and overseeing operations to ensure they meet customer purchase orders, drawings, and specifications, and processing requirements.
The selected candidate will be responsible for:
Conduct visual and dimensional inspection using caliper, micrometer, pin gage, snap gage, force gage, optical comparator, high resolution vision system, laser scan micrometer, etc.Able to conduct part testing using tensometer, material hardness tester, rheometer and equipment testing using thermocouple thermometer, cleanroom particle counter, etc.Conduct and complete First Article Inspection and report per AS9102.Conduct receiving inspection.Perform thorough inspections of incoming raw material, finished goods, including hardware and processed parts from vendors, as well as customer-supplied material.Verify all necessary documents are received and in compliance with all requirements of the purchase order.Perform in-process inspection throughout the manufacturing process.Conduct final inspection. Responsible for final inspection and stamp of approval on Quality Control Document before processing paperwork for shipment to customers.Ensure that all completed operations on job traveler are properly documented.Perform dimensional and visual inspection of product in accordance with customer Purchase Order (PO), blueprint, drawing, checklist, part list, etc.Generate First Article Inspection Reports (FAIR) and/or Dimensional Inspection Data Reports as applicable.Confirm part marking and unit packaging, and all documentation required with the product shipment.Support SPC data collection and documentation when applicable.Support and perform tool inspection/calibration, internal equipment calibration, maintain calibration records, documentation, and scheduling as assigned.Provide quality inspection technical support.Educate and train manufacturing personnel on more appropriate inspection methods and techniques whenever necessary.Support MRB and RMA material inventory and disposition.Write material/product nonconformance reports and corresponding internal quality alerts.Participate in completing RCCA reports and effectiveness evaluation.Enforce and maintain complete and accurate quality department document control.
The selected candidate will also possess:
Salary Range: $21 to $23/hour
More information can be found at www.simplybiotech.com
Company DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.Company DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices. Read Less
Quality Control Chemist - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a Quality Control Chemist in San Diego, CA who possesses:
Bachelor's degree in Chemistry, Biochemistry, or a related field1+ years of cGMP lab experience; pharmaceutical or biotech experience preferredExperience with analytical instrumentation, including HPLC, GC, or related equipment
FULL DESCRIPTION: We are seeking a Quality Control Chemist to perform testing on raw materials, in-process samples, and finished products within a compliant laboratory environment. This role is responsible for analytical testing, sample and solution preparation, accurate documentation, equipment calibration, laboratory cleanliness, and identifying potential quality issues. The ideal candidate will have a chemistry or biochemistry background, cGMP lab experience, strong technical documentation skills, and hands-on experience with analytical instrumentation.
The selected candidate will be responsible for:
Performing analytical testing on raw materials, in-process samples, and finished productsUsing analytical instruments such as HPLC/UPLC, GC, MS, FTIR, LC/MS, and related equipmentPreparing samples and solutions according to established methodsCalibrating and maintaining laboratory equipmentDocumenting all work in compliance with cGMP requirementsIdentifying and reporting quality issuesSupporting corrective actions as neededAssisting with SOP updatesMaintaining laboratory cleanliness and organizationSupporting a compliant laboratory environmentManaging testing priorities accurately and efficientlyWorking both independently and as part of a teamFollowing laboratory procedures, safety standards, and documentation requirementsPerforming other duties as assigned
The selected candidate will also possess:
Bachelor's degree in Chemistry, Biochemistry, or a related field required1+ years of cGMP laboratory experience requiredPharmaceutical or biotech lab experience preferredExperience with analytical instrumentation requiredExperience with HPLC, GC, or related equipment preferredExperience with HPLC/UPLC, GC, MS, FTIR, or LC/MS preferredStrong attention to detailStrong technical documentation skillsAbility to follow established laboratory methods and proceduresAbility to identify and report potential quality issuesAbility to manage priorities in a laboratory environmentAbility to work independently and collaboratively on a teamAbility to work onsite in San Diego, CAAbility to support a temporary-to-hire opportunity
Physical Requirements:
Ability to sit, stand, walk, bend, reach, and move throughout the laboratory during the workdayAbility to use hands and fingers for sample preparation, solution preparation, instrumentation, documentation, and computer workAbility to review laboratory data, test results, SOPs, batch records, and computer screens for extended periodsAbility to work with laboratory equipment, analytical instruments, samples, reagents, and related materialsAbility to occasionally lift, carry, or move standard laboratory supplies, samples, or equipment as neededAbility to work in a cGMP laboratory environment while following applicable safety, documentation, and quality proceduresAbility to wear required personal protective equipment as needed
Salary Range: $24 to $28/hour
More information can be found at www.simplybiotech.com.
HR Manager - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for an HR Manager in Bedford, NH who possesses:
Bachelor's degree in Human Resources, Business Administration, Industrial Relations, or a related field, or at least 5 years of progressive HR experience in a life science, manufacturing, or industrial settingStrong understanding of manufacturing operations and the dynamics of an hourly workforceExperience supporting a high volume of non-exempt employees
FULL DESCRIPTION: We are seeking an HR Manager to partner with Human Resources leadership, the HR team, and site leadership to deliver HR strategies, processes, and services in support of business goals. This role is responsible for executing people initiatives, supporting employee relations, coaching leaders, driving HR functional excellence, and supporting a manufacturing environment with multiple shifts. The ideal candidate will have strong HR leadership experience, manufacturing or life science industry exposure, employee relations experience, and the ability to support both strategic and hands-on HR needs.
The selected candidate will be responsible for:
Providing people-related solutions to business leaders to support high performance and professional responsivenessCollaborating with key management to provide strategic leadership and guidance on human resources policies, objectives, and initiativesHelping build, develop, and retain a diverse and highly qualified workforceSupporting special projects by identifying priorities, clarifying issues, coordinating requirements, evaluating options, and driving resultsProviding expertise, guidance, and tactical execution in talent management, performance, career development, succession planning, compensation guidance, employee relations, retention, engagement, and leadership effectivenessAligning HR initiatives with operational goals and business objectivesManaging day-to-day HR activitiesMentoring, developing, and coaching staff to achieve resultsProviding HR expertise to all levels of management and employeesAddressing root causes of issues through a systematic and analytical approachConducting and supporting employee relations investigations as neededTaking a hands-on approach while monitoring the pulse of employees to support strong engagementEnsuring HR programs and plans align with business prioritiesMonitoring HR program effectiveness through key metricsProactively identifying and addressing HR challenges and opportunities that may impact business plan executionApplying knowledge of legal requirements related to day-to-day management, coaching, counseling, career development, and disciplinary actionsMaintaining strict confidentiality in daily operationsSupporting a manufacturing environment with multiple shiftsWorking a flexible schedule as needed, including nights, weekends, and holidaysFollowing all cGMP, policies, procedures, and rulesMaintaining consistent attendance and punctualityPerforming other duties as assigned
The selected candidate will also possess:
Bachelor's degree in Human Resources, Business Administration, Industrial Relations, or a related field preferred5 to 10 years of related HR experience and/or training preferredProgressive HR experience in a life science, manufacturing, or industrial setting requiredStrong understanding of manufacturing operations and hourly workforce dynamics requiredExperience supporting a high volume of non-exempt employees requiredKnowledge and leadership experience across multiple HR disciplinesExperience with organizational diagnosis, employee engagement, leadership development, strategic staffing, performance management, talent management, workforce effectiveness, succession planning, organizational development, legal compliance, rewards, or recognition preferredPHR, SPHR, SHRM-CP, or SHRM-SCP certification preferredIntermediate computer skillsAbility to perform complex computer tasks and use various computer programsStrong professional communication skillsAbility to speak, read, and write fluently and accurately for professional business needsStrong reasoning and problem-solving skillsAbility to define problems, collect data, establish facts, and draw valid conclusionsAbility to interpret technical instructions and work through abstract and concrete variablesAbility to effectively present information to various audiencesExcellent time management skillsWillingness to make decisionsAbility to work independently and as part of a teamStrong confidentiality, judgment, and professionalismAbility to work onsite in Bedford, NHAbility to support a flexible schedule as needed
Physical Requirements:
Ability to sit and work at a computer for extended periodsAbility to communicate by phone, email, video meeting, and in person throughout the workdayAbility to review HR documentation, employee records, reports, policies, investigations, performance materials, and computer screens for extended periodsAbility to use hands and fingers for typing, data entry, documentation, filing, and standard office tasksAbility to occasionally stand, walk, bend, reach, and move throughout office, production, and manufacturing areas as neededAbility to occasionally lift, carry, or move standard office files, documents, or suppliesAbility to work in office and manufacturing-adjacent environments while following applicable safety, HR, and cGMP proceduresAbility to wear required personal protective equipment as needed when entering manufacturing or production areas
Salary Range: $85,000 to $95,000/year
More information can be found at www.simplybiotech.com.
QC Manager - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a QC Manager in Anaheim, CA who possesses:
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related technical field; must be able to pass education verification5 to 7 years of progressive experience in Quality Assurance or Quality Control, including at least 3 years in a managerial roleExperience in a cGMP-compliant environment; personal care, cosmetics, or OTC manufacturing experience strongly preferredDeep understanding of FDA regulations, including 21 CFR 210/211, ISO 22716, GMP for cosmetics, and related quality standards
FULL DESCRIPTION: We are seeking a QC Manager to oversee Quality Assurance and Quality Control functions across manufacturing activities. This role is responsible for ensuring products meet internal specifications, customer requirements, and regulatory standards while leading the implementation and continuous improvement of the Quality Management System. The ideal candidate will have strong QA/QC leadership experience, cGMP experience, knowledge of FDA and ISO quality standards, and the ability to lead quality staff in a fast-paced manufacturing environment.
The selected candidate will be responsible for:
Leading QA and QC teams, including training, development, and performance managementDeveloping, implementing, and maintaining a robust Quality Management System in compliance with GMP, FDA, ISO 22716, and customer standardsOverseeing quality-related activities, including raw material testing, in-process checks, customer component AQL, finished goods inspection, and batch record reviewInvestigating and resolving quality issues, including non-conformances, deviations, customer complaints, CAPAs, and root cause analysesEnsuring timely review and approval of production and laboratory documentation to support product releaseManaging internal auditsCoordinating external audits, including customer and regulatory auditsEnsuring timely resolution of audit findingsPartnering with R&D, Regulatory, Production, and Supply Chain to support product development, scale-up, and commercializationMaintaining and reporting quality metrics and KPIsDriving continuous improvement initiativesEnsuring calibration and maintenance of laboratory equipmentOverseeing environmental monitoring and cleaning validation, if applicableStaying current with changes in regulatory requirementsEnsuring ongoing company compliance with applicable quality and regulatory standardsPerforming other duties as assigned
The selected candidate will also possess:
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related technical field requiredMust be able to pass education verification5 to 7 years of progressive experience in Quality Assurance or Quality Control requiredAt least 3 years of managerial experience requiredExperience in a cGMP-compliant environment requiredPersonal care, cosmetics, or OTC manufacturing experience strongly preferredDeep understanding of FDA regulations, including 21 CFR 210/211, requiredKnowledge of ISO 22716, GMP for cosmetics, and related quality standards requiredStrong leadership skillsStrong problem-solving skillsStrong written and verbal communication skillsExperience with QMS platforms, LIMS, and document control systems preferredAbility to manage multiple priorities in a fast-paced, deadline-driven environmentAbility to support audits, investigations, CAPAs, deviations, and root cause analysisAbility to work collaboratively with R&D, Regulatory, Production, and Supply Chain teamsAbility to work onsite in Anaheim, CA
Physical Requirements:
Ability to sit, stand, walk, bend, reach, and move throughout office, laboratory, quality, and manufacturing areas during the workdayAbility to communicate by phone, email, video meeting, and in person throughout the workdayAbility to review batch records, quality documentation, audit records, SOPs, regulatory standards, reports, and computer screens for extended periodsAbility to use hands and fingers for typing, documentation, data review, laboratory record review, and standard office or quality tasksAbility to occasionally lift, carry, or move standard office, laboratory, or quality materials as neededAbility to work in manufacturing, quality, or laboratory-adjacent environments while following applicable safety, quality, and cGMP proceduresAbility to wear required personal protective equipment as needed
Salary Range: $140,000/year
More information can be found at www.simplybiotech.com.
