Wayne Metro Area, NJ
- Assists Analytical & Process Science on authoring developmental protocols and reports, as necessary.
- Creation and revision of GMP documentation including Production Batch Records, Standard Operating Procedures, and related documentation.
- Coordination of timelines, document revisions and review cycles for all GMP documents including delegation to the appropriate groups for review to ensure timely production start dates.
- Driving the continual improvement of GMP Batch Records and SOPs between review cycle by soliciting and incorporating feedback from Analytical & Process Science, Engineering, and Quality groups.
- Review of completed batch records and other GMP documents in collaboration with Quality Assurance as needed to ensure accuracy and completion in accordance with cGMP regulations.
- Coordinates and develops with Analytical & Process Science, Engineering and QA Teams qualification projects and plans and identifies the critical to quality parameters impacting qualification activities.
- Supports preparing Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification documents/programs.
- Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Policies.
- Knowledge of biopharmaceutical unit operations for production of cell therapies is preferred.
- Qualification experience or applicable experience in a related area in the Pharmaceutical industry.
- 5+ years of Pharmaceutical industry experience and 5 + years of Facilities, Utilities, Equipment and Analytical Instruments.
- 3+ years of experience in a GMP environment or relevant GMP documentation experience.
- Proficiency in standard word processing software and project management software is required.
- Mandatory professional skills including knowledge of cGMPs for biopharmaceuticals, organized and disciplined record keeping, excellent communication skills, an ability to work effectively with others in a dynamic environment, and the ability to self-motivate, multitask, and meet tight deadlines
- BS degree in Scientific discipline or other related field with significant prior experience or equivalent.