QC Analyst I-Cell Culture

Organogenesis - Norwood, MA

Full-time - Entry Level

Norwood, MA

Merchant Wholesalers, Durable Goods

About the position

The QC Analyst I, Cell Culture performs quality activities in support of product production and release for ASA Product. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst I performs a variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. This position also requires the use of repetitive hand movement e.g. micropipettor and keyboard use for moderate or long periods of time. Occasional Class 10K gowning and off hours work is required in support of QC activities.

Responsibilities

• Responsible for daily lab housekeeping and maintenance, including temperature charting, restocking, cleaning and sample receipt, logging and disposition.
• Routine and non-routine testing of ASA in support of Stability, Process Validation and Method Validation.
• Responsible for reporting and reviewing final product results.
• Participates in data analysis and review.
• Interacts with Quality Assurance, R&D and Manufacturing.
• Works closely with the QC Chemistry lab in support of cell-based potency assays.
• Participates in receipt, inspection and transfer of tissue donations for both the ASA and Affinity Product lines.
• Participates in review and execution of feasibility/validation protocols.
• Collaborates on deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
• Revise/Review of SOPs.

Requirements

• Requires a minimum of bachelor's degree in biology or related field, with 1-3 years of related experience.
• Lab experience required.
• Experience in Biologics/chemistry, GMP regulated environment preferred.

Benefits

• Competitive Pay
• 401K - generous employer match with immediate vesting and financial planning resources
• Education Assistance Policy - $5,000 per year for all employees
• Medical, Dental and Vision
• Flexible Spending Account or Health Savings Account
• Wellness Program
• Three weeks of vacation, 4 floating holidays, sick days, and company holidays
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint