QA Documentation Specialist II
Job Req code: 713
Category: Quality Systems
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. Empowering Healing.
Organogenesis corporate headquarters is located in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds). Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products.
The QS Documentation Specialist III supports creation of standard operating procedures for quality activities in support of validation, production and release activities. The position has a great deal of interaction with many other departments, including Validation, Facilities, Production, Purchasing/Materials, Quality Assurance, Quality Control, Regulatory, and Logistics. The primary responsibilities of the QS Documentation Specialist III are review, routing and approval responsibilities of documents in Part 11 compliant electronic system (Pilgrim).
• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for all projects.
• Perform routing, review, and approval activities in Part 11 compliant electronic system.
• Ensures the issuance of production batch records (MBR's), Nonconforming Material Reports (NCMR's), Deviations, GMP Investigations, MS item numbers, Part Numbers, and Out-of-specification Numbers.
• Maintain databases for Document Control inventory.
• Maintain archival of all GMP records per established process.
• Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods.
• Communicate any areas of deficiency to the responsible individuals.
• Contribute as the documentation representative on cross functional project teams.
• The qualified candidate must have previous Documentation/Quality experience in Pharmaceutical/Medical Device industry.
• Be familiar with Microsoft Office.
• Be able to work independently.
• Possess strong organizational skills and have good written and verbal communication skills.
• Minimum Associates degree with 2+ years of experience in GMP environment.
• Candidate will be a highly motivated and creative individual with strong hands-on skills.
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