Edison-New Brunswick 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.
Coordinates the activities of other Technical Writers to deliver on the overall plan
Acts as project leader. Prepares and maintains the plan for preparation of all required documentation (SOPs etc.) to support the overall project plans
Coordinates the activities for documentation preparation with all stakeholders.
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 company 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.
10+ years of Pharmaceutical industry experience and 5+ years of Facilities, Utilities, Equipment and Analytical Instruments.
Experience from Quality Assurance and Project Management preferred.
5+ 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.