QA Specialist Internal Audit III/IV
Job Req code: 955
Category: Quality Systems
Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities 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.
The Quality Assurance Compliance department provides overall direction for the Quality Management System at the Massachusetts campus and other manufacturing/distribution locations in the US and abroad. This department has responsibility for ensuring compliance with Corporate Standards, Current Good Manufacturing Practices (CGMP), and applicable regulatory requirements.
The role of QA Specialist, Internal Auditing, leads the internal audit program at multiple locations with responsibility for scheduling, coordinating, and executing audits across various functional areas of all CGMP operations. This QA Specialist will also be required to cross-train to support other functions within QA Compliance including Supplier Quality, Complaints Handling, Change Control, and Risk Management.
- Plan and conduct internal audits in accordance with internal audit program to ensure compliance with applicable regulations, internal policies and procedures and other applicable requirements.
- Update the internal audit schedule as needed and execute audits per approved schedule.
- Generate timely audit reports and work with personnel to effectively address observations and findings elevating when necessary
- Ability to work well in a cross functional team environment.
- Must be well versed in FDA trends and regulations with a strong aptitude for applying a balanced approached to specific situations.
- Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
- Provide status updates in support of monthly quality reports and Management Review of the Quality System
- Support FDA and 3rd party audit inspection activities and track responses to audit observations
- Ensure continued compliance with product specific regulations including FDA 21CFR 820, 200, 600, 1270, and 1271, applicable guidelines and standards, and current best industry practices.
- Initiate and lead cross-functional teams to support department and company goals. Generate and distribute meeting minutes.
- Cross-train and contribute to other functional areas within QA Compliance (i.e., Supplier Quality, Complaints Handling, Change Control, and Risk Management) as an integral team member within a matrix-oriented structure.
- Partner with External Auditor(s) participating in external audits of new and existing raw material suppliers, contract manufacturers, and testing laboratories assisting in audit planning, conducting the quality audit, preparing audit reports, follow-up to responses and maintaining the approved supplier list.
PREFERRED EDUCATION AND EXPERIENCE
- Requires a Bachelor’s degree in biological sciences, engineering, biomedical, or related field of study with a minimum of 5 years of direct CGMP QA auditing experience within the medical device, bio-pharmaceutical, or biotechnology industry
- Master’s degree preferred
- Advanced working knowledge of aseptic processing guidelines would be highly desirable along with certification as an auditor.
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