We are seeking an experienced, team-oriented, and responsive Quality Assurance Manager. This full-time position offers your choice of a 4 or 5 day work week, competitive benefits, growth opportunities, and a culture of life-work balance.
The Quality Assurance Manager is responsible for the execution, oversight, and continuous improvement of Quality Assurance processes supporting manufacturing and Client programs. The Quality Assurance Manager ensures effective implementation of the Quality Management System (QMS) through management of quality subsystems (CAPA, complaints, nonconformance, audits) and cross-functional support of day-to-day operations. This will be done in alignment with BIOLYPH’s business model of producing our Clients’ IVD/RUO products Effectively, Efficiently, and Economically.
Essential Functions:
Quality Management System:Execute and maintain assigned QMS subsystems in alignment with ISO 13485 and 21 CFR 820 requirements Monitor and analyze quality metrics (NCRs, CAPAs, complaints, audit findings) and escalate risks or adverse trends Drive timely closure and effectiveness of quality records Support Management Review through data preparation and trend analysisOwn and manage CAPA, Nonconformance, and Complaint Handling systems, ensuring:Timely initiation, investigation, and closure Robust root cause analysis (5 Whys, Fishbone, etc.) Verification of effectiveness (VOE) Identify systemic issues and escalate to Senior Quality Manager as neededAudit System:Lead internal audits and support external audits (Client, registrar, regulatory) Serve as primary point of contact for audit logistics, responses, and follow-up actions Ensure audit observations are appropriately documented, investigated, and trendedProduction Support:Champion BIOLYPH's goal of Perfect Finished Parts and promote a culture of continuous improvementProvide real-time quality support to manufacturing operations Ensure product and process adherence to specifications and proceduresPartner with Engineering and Operations to resolve quality issues and prevent recurrenceClient Support:Maintain strong, professional relationships with Client Quality representativesSecondary Job Functions:
Perform miscellaneous duties and projects as requiredQualifications:
Bachelor's Degree in Life Sciences, Engineering, or related field Minimum 7 years of experience in quality assurance within a regulated industry, with a minimum of 2 years of experience in a management role.Experience with quality subsystem ownership Experience supporting external audits (preferred)Strong knowledge of QMSR (21 CFR 820), ISO 13485, ISO14971 and MDSAP (preferred)Quality certification, CQIA, CMQ, or CQE (preferred)Other Requirements:
Strong problem-solving, communication, and documentation skills Interpersonal, negotiation, time management, and prioritization skillsDemonstrated use of risk-based thinking Well organized, pays attention to detailsExcellent computer skills (Outlook, Word, Excel)Capable of applying Quality Tools to diverse situationsProven leadership and team management experienceProject ManagementCapable of working independently and as a teamMust be able to wear appropriate PPEAbility to sit for extended periods of timeNormal vision acuity (with or without corrective lenses)Ability to identify and distinguish colorsAbility to lift 10lbs routinely/often/occasionallyAbility to crouch, bend, twist and reachAbout BIOLYPH:
Established in 1993, BIOLYPH is a dynamic, World-Class Contract Lyophilization and Component Packaging Service Company located in Chaska, Minnesota. BIOLYPH has maintained a workforce that is collaborative and innovative.
BIOLYPH Offers:
Competitive pay commensurate with experienceBenefits for full-time employees include:Health, Dental, Vision, Life, Short-term, and Long-term disability insurancePaid Time Off, Paid Holidays, including Floating Holidays, Paid Birthdays401kEmployee Assistance ProgramFrequent company-sponsored eventsClean, friendly, and collaborative work environment Read LessBIOLYPH is growing! We are seeking an experienced, team-oriented, and responsive Client Service Facilitator. This full-time position offers your choice of a 4 or 5 day work week, competitive benefits, and a culture of life-work balance.
Our Client Service Facilitator engages with and talks to our Clients to build positive relationships and act as a liaison between our Clients and the Production Team. This will be done in alignment with BIOLYPH’s business model of producing our Clients’ IVD/RUO products Effectively, Efficiently, and Economically.
Essential Functions:
Cultivate lasting relationships with Clients, providing personalized, high-quality serviceAct as the initial point of contact to professionally resolve complex Client inquiriesRespond to Client emails and phone callsConsult with other departments regarding Client needsFacilitate Production requestsDraft Production documentsAssist in planning and coordinating the activities of the Production TeamSupport our Quality Assurance Team with Client communicationPrepare price quote proposals as neededCoordinate the receipt, delivery and shipment of Client materialsAssist the Inventory Team with cycle counts and Client communications Participate in and facilitate meetings with current Clients as needed.Route incoming communications to appropriate personnelMaintain Client recordsSecondary Job Functions:
Create and edit documents as needed on behalf of the Managing Director via transcription, formatting and editing as appropriateTradeshow duties and responsibilities as neededMiscellaneous projects as requested Other duties as assigned by ManagementQualifications:
Experience / EducationHigh School diploma or equivalent3+ years of related experienceOther Requirements:
Provide effective and efficient communication and supportHandle confidential business matters appropriatelyWell organized, pays attention to detailsExcellent computer skills (Outlook, Word, Excel)Self-motivatedCapability to work independently and as a teamMust be able to wear appropriate PPE as needed Ability to sit for extended periods of timeNormal vision acuity (with or without corrective lenses)Ability to identify and distinguish colorsAbility to lift 10 lbs routinely/often/occasionallyAbility to crouch, bend, twist and reachAbility to push/pull 25 lbs occasionallyAbout BIOLYPH:
Established in 1993, BIOLYPH is a dynamic, World-Class Contract Lyophilization and Component Packaging Service Company located in Chaska, Minnesota. BIOLYPH has maintained a workforce that is collaborative and innovative.
BIOLYPH Offers:
Competitive pay commensurate with experienceBenefits for full-time employees include:Health, Dental, Vision, Life, Short-term, and Long-term disability insurancePaid Time Off, Paid Holidays including Floating Holidays, and Paid Birthdays401kEmployee Assistance ProgramFrequent company-sponsored eventsClean, friendly, and collaborative work environment Read Less