QC Analyst II/ III - Microbiology
150 Dan Road, Canton, Massachusetts, 02021, United States
Job Req code 309
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 III performs complex quality activities in support of product production and releases. The position has interaction with other internal departments, including Apligraf Production, FortaFlex Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interaction with external entities including contractors and suppliers. The QC Analyst III performs a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
How You Will Achieve It:
- Perform endotoxin, microbiologic, and water testing.
- Perform and/or read environmental, personnel, and in-process sterility testing.
- Prepare and send out samples for microbiological identification and/or mycoplasma testi
- Perform visual inspection of finished products
- Generate trend reports as they relate to quality testing.
- Revise SOPs.
- Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
- Identifies and implements issues and opportunities for improvements.
- Participate extensively in high-level quality systems programs (CAPA, etc.).
What You Need to Achieve It:
- Requires a Bachelor's Degree or equivalent, with a minimum of 3-5 years of related experience in a GMP/GLP regulated environment.
- Microbiology experience required.
- Proven technical proficiency and demonstrated skills in quality technology practices.
- Demonstrates understanding of relatively complex data with proficiency to problem solve.
- Advanced working knowledge of statistics. Proficient in the use and application of quality tools, databases, and process skills.
- Advanced knowledge of relevant Quality System and SOP procedures. Advanced knowledge of industry regulations and standards such as FDA, USP, and/or ISO, with an ability to interpret and apply quality and regulatory standards.
- Advanced working knowledge of tooling, test equipment, laboratory techniques, and good laboratory practices (cGLPs). Advanced product testing using endotoxin or kinetic methodologies.
- Understands documentation systems
- Communicates advances non-compliant issues back to the end users of the Document Control Procedures.
- Requirements include following gowning procedures, usually lab coats, gloves and sleeves.
- The working environment includes working with chemicals such as strong acids and bases and will also involve exposure to human tissue products.
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.