Cell Therapy QC Associate

Position Title : QC Associate II

Work Location: 9 Technology Drive, Westborough, MA, 01581

Assignment Duration: 12 months

Work Arrangement: Mon – Friday (onsite)

Description :

Purpose & Scope: AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Analytical Associate II. This position provides Quality Control compliance, commercial readiness, and testing support for AIRM cell therapy products. Looking for a strong GMP and scientific background and experience with quality control testing of cell based therapies.

Organizational Context : Reporting to QC Scientist I Terrence Tamakloe

Essential Job Responsibilities:

• Perform routine in-process and release QC testing of AIRM cell products.
• Execute GMP analytical assays such as Immunofluorescence, Flow Cytometry, PCR, Viability, Cell growth and various parenteral assays (Visual Appearance, Content Uniformity, pH, Osmolality).
• Perform analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
• Maintain, calibrate and operate GMP equipment and instruments supporting QC testing.
• Track and test products according to stability protocols.
• Culture and maintenance of cell lines and stem cells.
• Work with internal and external resources to maintain lab in a GMP state.
• Monitor and trend QC data.
• Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stablity.
• Perform shipment of materials for QC testing to contract labs and perform data review.
• Author, revise and review SOPs, qualification/validation protocols and reports.
• Conduct investigations regarding out of specifications (OOS) results. Assist and manage deviations and CAPAs related to analytical procedures.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Perform QC lab duties and technical projects as required.

Quantitative Dimensions :

• This position interacts with Quality Control, Analytical Development, Drug Product Development, Manufacturing and Quality Assurance. Will contribute to the development of QC departmental processes.

Qualifications:

Required

• Bachelors degree in biotechnology or related field with 3+ years of Quality Control experience, or a Master’s degree in biotechnology or related field with 0-2 years of Quality Control experience.
• Relevant GMP experience in the quality control department of a biotech and/or pharmaceutical industry.
• Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.

Preferred

• Experience with relevant analytical test methods: including PCR, Flow Cytometry, IFA and cell based assays
• Experience with ICH guidelines and parenteral test methods
• Experience with 21CFR Part 11 Compliance
• Experience with the qualification of Analytical Test Methods
• GMP Cell Culture experience and Environmental Monitoring
• Experience with data tracking/trending analysis

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