Documentation Specialist jobs in Brockton, MA

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

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 QS Documentation Specialist II supports the documentation activities in support of product production and release. The position has a great deal of interaction with many other departments, including Production, Purchasing, Materials, Quality Assurance, Quality Control, Regulatory and Logistics. The primary responsibilities are SmartSolve Document Management routing and approval, ensuring security and easy retrieval of the controlled files, batch record issue and supporting production needs.

• Perform SmartSolve Document Management routing, review, and approval activities. Issue training Packets, as needed.
• Issue batch records (MBR's) to Production weekly, as well as OOS’s to the appropriate individuals as needed
• Maintain databases for Document Control room inventory
• Control and maintain Device Master Records, Equipment History Files, and Process Flow Diagrams
• Responsible for filing and maintaining archived documents.
• Responsible for assisting with the destruction of documents that are outside of the required retention period and/or assisting with the preparation of records for storage offsite
• Responsible for ensuring that records are maintained, secure, and retrievable throughout defined record retention periods
• Review Facilities documentation for compliance prior to filing in the Equipment History Files.
• Communicate any areas of deficiency to the responsible individuals
• Maintaining the cell bank database in Excel by entering new binders into inventory and tracking the hard copies taken for reference.
• Scan and make copies as necessary