Quality Systems Documentation Specialist III

Norwood, MA

Job Req code: 882

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 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).

Job Responsibilities:

  • Participate in the creation and/or review of Standard Operating Procedures (SOPs) for all projects.
  • Perform a thorough quality review of all SOPs for compliance, in addition to fixing format, grammar, etc.
  • 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

Requirements

The candidate must have previous Documentation/Quality experience in Pharmaceutical/Medical Device industry, be familiar with Microsoft Office, able to work independently and have strong organizational skills and have good written and verbal communication skills. A minimum Associates degree with 2+ years of experience in GMP environment is required.