GMP Documentation Control / Training Specialist

Job Title: GMP Documentation Control / Training Specialist
Job Location: Cranbury & South Plainfield NJ
Direct Report: Head of Quality Assurance

Job Summary:
This position is responsible for supporting J-STAR’s Quality System to ensure adequate control of GMP documentation and coordination of training activities. Maintaining lists of GMP equipment and tracking PMs, calibrations and qualifications is also included. Specific responsibilities of the position include, but are not necessarily limited to, the items listed below.

Primary Responsibilities:

• Help maintain J-STAR’s Quality System in a manner consistent with FDA/ICH requirements for GMP manufacture and testing for APIs in early clinical phases.
• Support management and maintenance of the SOP and Document Control system.
• Serve as the Document Control role in electronic systems management, including DMS, TMS and QMS.
• Support lifecycle management of GMP documents including document archival. Maintain inventory list(s) of GMP documents as needed.
• Track the periodic review status of SOPs to ensure that they remain up-to-date.
• Ensure that GMP documentation (e.g., SOPs, Batch Records, Cleaning Records, Training Records) is properly stored.
• Maintain training documentation (folders) for GMP personnel. Keep folder contents in a state of inspection readiness. Track the completion of annual training assessments forms (G-025).
• Issue logbooks as needed. Ensure proper close-out of retired logbooks.
• Help prepare for and participate in GMP audits as needed.
• Maintain instrument/equipment calibration list and equipment PM list per G-300 and P-206.
• Track PMs and calibrations/ qualifications to ensure all GMP equipment and instruments is in-date.
• Serve as the training management system coordinator to properly manage training related documents, including TMS electronic system.
• Other QA duties assigned by supervisor.

Qualifications:

• Education: Bachelor’s degree or equivalent experience.
• Experience: Minimum of 3 years of experience in document control within the CDMO or pharmaceutical industry. Experience with electronic systems is preferred.
• Technical Skills: Knowledge of GMP guidelines, and regulatory requirements. Proficient in using Microsoft Office.