Goodwin Biotechnology

Scope of Function:  Design and develop electronic document management systems (EDMS) Oversee the implementation of quality systems and Standard Operating Procedures for compliance of appropriate GMP regulations for manufacturing and testing.

Reports to:  Associate Vice President, QA, QC & Operation Planning

Specific Duties:

  1. Manage/Supervise staff for QA System Compliance Group, including Document Control, Training and QA Facilities management.
  2. Review, revise, edit and format Standard Operating Procedures, Logbooks, Specifications, Batch Records and other documentation according to written procedures.
  3. Structure, organize, upload and maintain electronic documents onto the client’s ftp site or other server as needed.
  4. Maintain storage of Master Files and executed documents in accordance with internal procedures.
  5. Label generation and reconciliation.
  6. Spearhead the transition of paper-based system to electronic document management systems (EDMS).
  7. Enhance Quality Systems Policies to reflect industry best practices. Identify procedural gaps/improvements for transition to commercial testing and manufacturing. Work in tandem with subject matter experts to address gaps.
  8. Ensure the Quality Systems readiness for regulatory and customer inspections.
  9. Handle, investigate and close Incident reports, Deviations, Investigations, Change Controls and CAPAs.
  10. Perform QA review and approval all equipment master records, IQ/OQ/PQ, transfer forms, status change forms, calibration and preventive maintenance records.
  11. Establish Data Integrity program for all relevant equipment to ensure compliance with 21CFR part11.
  12. Perform Room/Equipment Compliance and clearance activities as needed.
  13. Review environmental monitoring data; viable/non-viable particulate; temperature/humidity /air pressure differential Amega data to determine the compliance of the room/equipment. Responsible for working with all relevant parties to address excursions.
  14. Collate Quality Systems metrics in preparation for quarterly Management Review meetings and Monthly metrics.
  15. Administer QMS routine meetings such as Deviation and change control.
  16. Participate as needed in client audits as well as regulatory audits.
  17. Maintain all establishment licenses.
  18. Serve as the Officer QA liaison for DEA.
  19. Submit Annual Updates of DMF to FDA.

Education:

Bachelor’s degree in Life Sciences or a related scientific field.

Experience:

Minimum of seven years’ experience working in a FDA regulated environment.

Skills:

Proficiency with technical writing and written and verbal communication.