Qc Analyst Ii/ Iii-Chemistry

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space 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 strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The QC Analyst II/III performs advanced quality activities in support of product production and releases. 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 II/III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. This position also requires 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:

• Scientific/technical contributor on cross-functional projects related to all QC Chemistry activities and Bioassay development
• Perform visual inspection of finished product.
• Work closely with the QC Cell Culture lab in support of ELISA testing for potency based assays.
• Generate trend reports as they relate to quality testing.
• Coordination of test sample receipt and scheduling.
• Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
• Primary responsibility for the day-to-day activities in the QC Chemistry laboratory in support of product release testing
• Donated tissue receipt, inspection and transfer
• Revise/Create SOPs.
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
• Data analysis and review
• Identify and report areas for process improvement
• Interact and coordinate with Manufacturing on a daily basis.
• Generate and execute feasibility/validation protocols

What You Need to Achieve It:

• Bachelor’s degree in biology or related field, with
• 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.
• 5-7 years of related experience. Lab experience required. Experience in Biologics/chemistry, GMP regulated environment preferred. .

What can we offer you?

• - generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Employee Assistance Program
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Education Assistance Policy - $5,000 per year for all employees
• Free parking including an electric charging station (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Paid maternity leave and parental leave for all new parents
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Adoption benefits

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, genetic information or any other characteristic protected by law.