Quality Assurance Specialist III

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 disposition of multiple product releases. The position has a great deal of interaction with many internal departments, including Apligraf Production, FortaFlex Production, Cell Culture, Facilities, Validation, Calibration, Materials, Quality Control, and Materials Management. The position may also have interactions with external entities including contractors, suppliers, and customers. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory.

How You Will Achieve It:

• Review batch records to support new and existing products.
• Assist in all activities associated with transferring multiple product lines for shipment
• Review internal document for accuracy and compliance with GMP’s
• Participate in cross-functional teams to support department and company goals
• Perform additional QA functions as required
• Support special project team activities, as needed.
  
  
  

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
  
  
  

The anticipated annualized base salary for this role is $85,000-$99,000 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.

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.

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.