Quality Assurance Specialist II/III

We are a leading regenerative medicine company in the advanced and acute wound care space, offering life-changing solutions through our comprehensive portfolio of skin substitutes and regenerative medicine products.

About the role

The QA Specialist performs quality activities in support of new product production and quality review and disposition for clinical and commercial product production. This role involves significant interaction with internal departments (Production, Facilities, Validation, Calibration, Materials, Quality Control, Logistics) and external entities (contractors, suppliers, customers). Responsibilities include ensuring compliance with regulatory requirements through documentation reviews, batch approvals, exception approvals, and validation approvals.

Responsibilities

• Review batch records and test records; perform final product inspection/release for 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.
• Provide recommendations 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.
• Coordinate daily activities within the assigned functional area.
• Support special project team activities as needed.

Requirements

• Bachelor’s degree or equivalent combination of education and experience.
• 5-8 years of GMP experience in the Medical Device/Biotechnology industry.
• Demonstrated knowledge of scientific principles in a GMP/GLP regulated environment.

Benefits

• 401k with generous employer match (immediate vesting) and financial planning resources.
• Comprehensive medical, dental, and vision coverage (effective day one).
• Flexible Spending Account (FSA) or Health Savings Account (HSA).
• Company-paid insurances: Short-Term Disability, Long-Term Disability, and Life Insurance; voluntary options available.
• Paid maternity leave and parental leave for all new parents.
• Adoption benefits.
• Education Assistance Policy: $5,000 per year for all employees.
• Wellness Program: free trainings on mental health, mindfulness, stress reduction, on-site flu shots, and more.
• Employee Assistance Program.
• Generous paid time off: vacation, floating holidays, sick days, and company holidays.
• Free parking (including electric charging stations at Canton and La Jolla locations).
• Discounts at BJ’s Wholesale, Dell, Sullivan Tire, and Sprint.

Pay

The anticipated annualized base salary for a Level II is $71,700–$83,200 and for a Level III is $85,000–$100,000. Base salary is part of a total rewards package that includes merit-based increases, 401(k) eligibility with company match, medical/dental/vision coverage, education assistance, life/disability insurance, and paid time off. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law.