QC Analyst II/III Materials - Organogenesis : Job Details

What You Will Achieve:

The QC Analyst II/III performs quality activities in support of quality disposition of materials: material inspection, material testing coordination, data collation, data review, material shipments, document updates etc. The position interacts with other internal departments, including Production Departments (Apligraf FortaFlex, Dermagraft, Trancyte, Human Tissue Manufacturing, Cell Culture, Cell Banking etc.), Quality Assurance, Materials Management, and Logistics. The position also has interactions with external entities including contractors, test labs and suppliers. The QC Analyst II/III performs a wide variety of activities to ensure compliance with applicable regulatory requirements in support of inspecting, coordinating testing, trending, and reporting results. The QC Analyst II/III will support QC Material compliance including but not limited to: Change Notifications, non-conforming raw materials, internal/external deviations, OOTr/OOS results etc. The QC Analyst II/III will support continuous improvement initiatives and participate in Quality System requirements for new and existing materials, e.g. risk management, CAPA and change controls. Periodic weekend, holiday and evening on-call coverage may be required.

This position directly supports all activities with QC Materials in direct support of Class II and Class III medical devices that will be manufactured in a new CGMP facility located in Rhode Island. This position will initially be based out of the Canton, MA facility requiring 20% - 50% travel between the Massachusetts Campus and the new facility in Smithfield, RI. Eventual home office at the RI facility with continued 20-30% travel to support Canton material activities as needed.

How You Will Achieve It:

• Perform material inspections.
• Perform tissue inspections.
• Submit test requests to the QC functional areas to coordinate testing.
• Coordinate shipping of materials to external test labs.
• Collate results and document results to submit to Quality Assurance for final dispositioning.
• Author and Revise SOPs.
• Generate trend reports as they relate to Quality Control testing, release metrics.
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
• Perform material related Quality System activities: Deviations; Non-conforming material reports; Internal Audit responses, risk assessments, change controls etc.
• Support material qualifications in compliance with company policies and applicable regulatory guidelines.
• Support continuous improvement projects.

What You Need to Achieve It:

• Bachelor's degree in science or equivalent.
• 4-7 years of related experience in a GMP regulated QC environment in support of FDA regulated Medical Devices and Biologics.
• Materials and/or final product inspection experience required.
• Pharmacopeia experience required.
• Local travel between OI production sites will be required (Canton MA, Norwood MA, Smithfield RI).
• On-site position.

Physical Requirements:

• Pass Annual Vision Screening Test.
• Able to lift 50 lbs. and 25-50% of time standing in workday.

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 role is $68,000-$81,000 and for a Level III is $81,000-$95,000 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.

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.