What You Will Achieve: The QA Specialist performs quality activities in support of new product production and quality review and disposition in support of clinical and commercial product production. The position has a great deal of interaction with many internal departments, including Production, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics. The position also has interactions with external entities including contractors, suppliers, and customers. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by performing documentation reviews both internally and externally, batch approval of produced product, exception approvals and validation approvals.
How You Will Achieve It: - Review batch records and test records and perform final product inspection/release in support of new and existing products.
- Review validation records to support new or improved processes and/or equipment release.
- Coordinate "Customer Service" meetings between QA and other departments.
- Give recommendations for action to be taken to resolve product and/or process issues.
- Participate in cross functional meetings for the production and release of clinical product
- Initiate and lead cross-functional teams to support department and company goals. Generate and distribute meeting minutes.
- Participates in coordinating daily activities within the assigned functional area.
- Support special project team activities, as needed.
Requirements What You Need to Achieve It: - Bachelor's degree or equivalent combination
- 5-8 years of GMP experience in a Medical Device/Biotechnology industry.
- Demonstrated knowledge of scientific principles in a GMP/GLP regulated environment is desirable
What can we offer you? - 401k -- generous employer match with immediate vesting and financial planning resources
- Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
- Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
- Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
- Paid maternity leave and parental leave for all new parents
- Adoption benefits
- Education Assistance Policy - $5,000 per year for all employees
- Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
- Employee Assistance Program
- Generous paid time off including vacation, floating holidays, sick days, and company holidays
- Free parking including an electric charging station (Canton and La Jolla)
- Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
The anticipated annualized base salary for a Level II is $71,700-$83,200 and for a Level III is $85,000-$100,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.
