Documentation Coordinator (368)

Milford, Massachusetts, United States
Sep 13, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
Equal Opportunity Employer

Purpose of the Position :

The position is responsible for maintaining quality records and operating document control systems for the site to ensure compliance with Current Good Manufacturing Practices (cGMP) and regulatory compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Guidance for Industry Q7Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

Key Job Responsibilities:

  • Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations
  • Maintains master indices and tracking of standard operating procedures, deviations reports, change control reports, technical reports, protocols, batch record files, validation reports and non-conformance reports
  • Coordinates documentation activities to ensure that procedures are written, edited, reviewed and approved in a timely manner to meet established deadlines
  • Ensure that documentation/records are indexed, filed, archived, retrievable and issued, consistent with Avecia's procedures and policies
  • Assist in the development, approval, and issuance of quality system documents
  • Assist in updating procedures specific to the Documentation Department
  • Works closely with other departments to support their documentation activities  (This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.)
  • Assist in continuous improvement initiatives
  • Strong attention to detail and self-checking skills

Job Knowledge Required:

  • The job requires a minimum of a high school diploma or equivalent and at least 1-3 years' experience in documentation systems preferable in an FDA regulated industry.
  • Must have good organizational skills.
  • Solid skills with Microsoft Word, Access and Excel.