What are the responsibilities and job description for the Quality Assurance Specialist II/III position at Organogenesis?
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 QA Specialist performs quality activities in support of new product production and CMO quality review and disposition in support of clinical 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 CMO produced product, exception approvals and validation approvals.
How You Will Achieve It:
- Review batch records to support new and existing products.
- 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 CMO 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.
Job 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
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.
Salary : $5,000
