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Technical Writer

Wayne Metro Area, NJ

Post Date: 06/25/2018 Job ID: JN -062018-21917 Job Type: Scientific
  • 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.

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