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Astrix
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  • Associate Director Quality Assurance (Indianapolis)  

    - Marion County
    Looking for a Pharmaceutical leadership role where you can shape quali... Read More
    Looking for a Pharmaceutical leadership role where you can shape quality operations, build strong teams, and influence the direction of a fast-growing organization? This opportunity is ideal for someone who thrives in startup or scale-up environments and enjoys creating structure, elevating standards, and driving continuous improvement. Pay: $140k-$160k Schedule: 1st shift Type of Job: Direct Hire Location : 100% On-site (Indianapolis area) At this time, Astrix cannot transfer nor sponsor a work Visa for this position. Relocation assistance is not available for this position. Associate Director, Quality Read Less
  • Downstream Manufacturing Associate (Morrisville)  

    - Wake County
    Position Summary: The Manufacturing Process Technician is responsible... Read More
    Position Summary: The Manufacturing Process Technician is responsible for executing GMP manufacturing processes including upstream and downstream operations, material handling, and batch documentation. This role ensures consistent production of high-quality clinical materials and supports the successful transfer of new processes into manufacturing. Morrisville, NC Contract (potential for conversion) Multi-shift availability (1st and 2nd shifts) Pay: $35$42/hour Looking for experience with AKTA Key Responsibilities: Perform manufacturing operations from cell expansion through purification following MBRs and SOPs Prepare buffers and support solutions; pack, qualify, and clean chromatography columns Operate and maintain analytical and manufacturing equipment in cleanroom environments Edit and maintain SOPs, logbooks, and batch documentation in accordance with GDP Coordinate with supply chain on raw material delivery, cleaning, and stocking Support waste decontamination and removal following EHS standards Enter production data into databases and assist with batch closeout activities Ensure compliance with cGMP, GDP, CFRs, and internal quality policies Collaborate with cross-functional teams on tech transfers and troubleshooting production issues Qualifications: Required: A.S. degree, Biomanufacturing certification, or equivalent experience Familiarity with FDA regulations, cGMP, and GDP documentation standards Effective communication skills and ability to work collaboratively in a team Flexibility to work varied shifts including nights and weekends Ability to lift 25 lbs routinely and up to 50 lbs occasionally Preferred: B.S. in Biochemistry, Bioengineering, Chemical Engineering, or related field 2+ years of GMP biologics manufacturing experience (e.g., cell culture, purification, aseptic fill/finish) Experience with single-use systems and GMP batch record management This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Read Less
  • Analytical Scientist (Middlesex County)  

    - Middlesex County
    We are seeking an Analytical Scientist to join a reputable pharmaceuti... Read More
    We are seeking an Analytical Scientist to join a reputable pharmaceutical manufacturing company to conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. ** No Relocation, No C2C Candidates** Pay: Up to $50/hour. RESPONSIBILITIES: Conduct and document chemical analyses for raw materials, in-process goods, and finished products. Design, validate, and resolve issues with analytical methods, including HPLC for cleaning verification. Collect and analyze equipment cleaning validation samples. Prepare Certificates of Analysis, analytical reports, and maintain lab documentation. Peer-review records and support OOS or OOT investigations as per SOPs. Ensure compliance with SOPs, cGMPs, and regulatory requirements. Assist with environmental monitoring and other tasks as assigned. QUALIFICATIONS: 2 years hands-on method development experience (HPLC) Knowledge of cGMPs, pharmacopeia (USP, EP), and regulatory standards (21 CFR Part 210/211/820, ISO). Bachelors in Chemistry-related discipline with 2+ years of analytical lab experience. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Read Less
  • Senior Process Engineer (Lake County)  

    - Lake County
    Our client is a global leader in the development and manufacture of ph... Read More
    Our client is a global leader in the development and manufacture of pharmaceutical ingredients/chemicals. This role offers a chance to join a highly respected organization known for its technical excellence, strong scientific culture, and deep expertise across all operational processes. Location: Lake County, OH Salary: $100125K Schedule: 1st Shift, MondayFriday (Onsite) Relocation Assistance Provided Essential Responsibilities Collaborate closely with chemists to guide the development of new chemical processes, translating R work hands-on with production operators to resolve issues. Support fellow engineers with complex scale-up scenarios. Prepare and maintain key documentation including batch records, specifications, hazard assessments, safety review packages, emissions data, and process reports. Conduct safety meetings, oversee ongoing production, assist on the manufacturing floor as needed, and review completed batch records. Work closely with chemistry and quality teams throughout the entire production cycle. Interface with external stakeholders such as clients, vendors, and contractors. Provide engineering support for pilot-plant equipment and infrastructure. Manage multiple priorities and work with leadership to set and adjust project goals. Required Education Read Less
  • Production Operator (Clackamas)  

    - Clackamas County
    A longstanding contract manufacturer of dietary supplements with relen... Read More
    A longstanding contract manufacturer of dietary supplements with relentless precision and cutting-edge technologies is seeking a Production Operator to join their growing team! 2nd shift and 3rd shift available! Great benefits! Pay : $28/hr DOE Schedules: 2nd shift: 2p-10:30p Mon-Fri 3rd shift: 10p-6:30a Sun-Thurs Type of Job: Temp to Hire Location : Clackamas, OR Responsibilities: Operate packaging machinery Set up, changover, breakdown, and make minor adjustments on machinery Troubleshoot issues Inspect capsules and packaged products Complete documentation Requirements: High school diploma or equivalent 1-3 years experience in pharmaceutical, nutraceutical, electronic, chemical, cosmetics, or food manufacturing required Experience with FDA regulations preferred Experience with packaging machinery preferred We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Read Less
  • Lead Engineer - OSD (Cincinnati metropolitan area)  

    - Hamilton County
    Were looking to hire a talented Lead Engineer I or a Process Engineer... Read More
    Were looking to hire a talented Lead Engineer I or a Process Engineer II with experience in oral solid dosage to help develop innovative treatments for chronic diseases. Apply todaythis is your chance to make a real impact in healthcare! Relocation assistance is available! Pay : $95k-$115k for the Lead Engineer I $85k-$100k for the Process Engineer II Location : Wilmington County, Ohio Responsibilities: Support the scale-up and transfer of oral solid dosage formulations and processes to the production facility Design and recommend equipment purchases Troubleshoot and maintain manufacturing systems, processes, and equipment Identify and implement process and equipment improvements Develop and implement SOPs Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations) Requirements: Lead Engineer I: BS degree in Engineering or technical discipline 5+ years of OSD pharmaceutical experience Experience with OSD equipment procurement Knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations Knowledge of OSD operations, statistics, equipment design, process control, process scale-up, and equipment validations Experience in statistical analysis Process Engineer II: BS degree in Engineering or technical discipline 2-5 years of OSD pharmaceutical experience Experience with OSD equipment procurement Knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations Knowledge of OSD operations, statistics, equipment design, process control, process scale-up, and equipment validations Experience in statistical analysis We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Read Less
  • Quality Control Analyst III (Ventura County)  

    - Ventura County
    Our client, a global CDMO, offering products and services across the d... Read More
    Our client, a global CDMO, offering products and services across the drug development spectrum is looking for a skilled QC Analyst III to join their team in Ventura County, CA! Job Title: QC Analyst III Location: Ventura County, CA Job type: 6 month contract - hire Pay rate: $37 - $39/ hr. Job Summary: We are seeking a highly skilled and detail-oriented Senior QC Analyst to perform complex analytical testing in support of pharmaceutical product development and manufacturing. The ideal candidate will have advanced experience in chromatography techniques (e.g., HPLC, UPLC, GC), method validation, data analysis, and regulatory compliance. This position plays a critical role in ensuring product quality, supporting investigations, and driving continuous improvement across the QC function. Key Responsibilities: Perform complex analytical testing including Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), and other instrumental and wet chemistry techniques. Troubleshoot analytical instruments and resolve method or equipment-related issues. Participate in and assist with test method validations, verifications, and transfers. Evaluate and analyze test data to identify trends, outliers, or potential issues. Support OOS (Out of Specification) and OOT (Out of Trend) investigations, including CAPA (Corrective and Preventive Action) documentation. Coordinate testing activities with external laboratories, including raw material and specialized testing. Execute, author, and review SOPs, test methods, protocols, reports, investigations, change controls, and data summaries. Utilize risk assessment and root cause analysis tools (e.g., 5 Whys, Fishbone) to support investigations and process improvements. Manage aspects of the stability program, including scheduling, testing, and reporting, and investigate aberrant stability results. Qualifications: Bachelors or Masters degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field. 36+ years of relevant experience in a regulated laboratory environment (pharmaceutical, biotech, or similar). Strong technical expertise in HPLC, UPLC, GC, and other analytical techniques. Working knowledge of cGMP regulations, ICH guidelines, and regulatory expectations. Experience with method validation and stability programs preferred. Ability to manage multiple tasks and work independently in a fast-paced environment. Experience with electronic data systems (e.g., Empower, LIMS, TrackWise, MasterControl). Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Read Less
  • Quality Assurance Specialist (Middlesex County)  

    - Middlesex County
    The QA Specialist will play a key role in ensuring the quality, safety... Read More
    The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. This position is responsible for reviewing raw material documentation, coordinating and reviewing raw material sampling and release, verifying QC data, and supporting the review of stability reports to ensure adherence to internal procedures, regulatory guidelines, and cGMP standards. Key Responsibilities: Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance. Perform raw material release activities in accordance with established SOPs and GMP requirements. Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody. Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications. Review and track stability reports , ensuring timely completion, accuracy, and adherence to protocols. Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data. Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation. Participate in internal and external audits, as needed. Identify and support opportunities for continuous improvement in quality systems and documentation processes. Qualifications: Bachelors degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required. 25 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry. Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles. Experience reviewing QC data, raw material documentation, and stability reports. Detail-oriented with strong organizational and documentation skills. Excellent communication and teamwork abilities. Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred. Read Less
  • QC Analyst (Chemistry - 1st shift) (Wilmington)  

    - Clinton County
    Our client, a global leader in the pharmaceutical manufacturing indust... Read More
    Our client, a global leader in the pharmaceutical manufacturing industry, is seeking a QC Analyst to join their team! - Pay: $25-30/hr ($25/hr for entry level/recent graduate) - Shift: 1st shift M-F GENERAL DESCRIPTION: The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff. KEY DUTIES: Perform testing in accordance with written procedures (i.e. USP/EP/JP grade) Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices. Processing of electronic data using procedures that ensure data integrity and security. Ship samples to contract testing facilities. Entry of test results from contract laboratories Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations. Transcribe results onto analysis reports. Perform daily standardization and performance verifications on laboratory equipment. Comply with site-wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security. Identify deviations to written procedures. Disposal of laboratory waste on an as needed basis. Identify and report unsafe conditions within the laboratory. Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation; perform investigative testing. SKILLS/ABILITIES: Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment. Understands paperwork review process. Ability to follow written procedures and exhibit excellent documentation practices. Basic laboratory knowledge and skills analytical techniques in wet chemistry/chromatography Practical experience with various types of laboratory instrumentation Troubleshooting skills with analytical methodology and instrumentation. Technical writing skills Employee must be able to pass a vision exam prior to employment and annually thereafter. PERSONAL ATTRIBUTES: Proactively achieves results for the best of the organization. Willingness to learn new things. Ability to function in a small company atmosphere. Ability to cope with a rapidly changing work environment. Commitment to teamwork. Commitment to continuous improvement in all areas. Ability to focus attention to details and ensure high quality work. Ability to work safely; seek out and encourage safe practices Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills EDUCATION AND EXPERIENCE: Bachelors Degree in Chemistry with 0-2 years of laboratory experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! Read Less

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