QC Analyst I - Chemistry

About Us We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: The QC Analyst I, Chemistry 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. 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. How You Will Achieve It: Responsible for daily lab housekeeping and maintenance. This includes 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 Cell Culture lab in support of cell-based potency assays. Performs visual inspection of vialed product. 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 What You Need to Achieve It: 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. TEST REQUIREMENTS Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition for employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards. What sets us apart? Competitive Pay 401K - vested immediately with 100% match 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 We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, or any other characteristic protected by law.

Created: 2024-10-19