Technical Writer Coordinator

Documentation, Technical Writer, Quality Assurance, CGMP, SOP, Batch Records
Contract Corp-To-Corp, Contract Independent, Contract W2, 6+ Months
Depends On Experience
Work from home not available Travel not required

Job Description

Job Title: Technical Writer Coordinator
Duration: 6+ Months (Estimated End Date: 09/02/2020)
Location: East Hanover, NJ
Description:
  • 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 & ldquo; critical to quality & rdquo; 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 clients policies.
Skills:
  • 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.
  • Leadership skills
Education:
BS degree in Scientific discipline or other related field with significant prior experience or equivalent
Required Skills:
Batch Records
Biopharmaceutical
CGMP
CGMPS
Documentation
Additional Skills:
Excellent Communication Skills
GMP
Leadership Skills
Operations
Project Management
Quality Assurance
SOPs
Technical Writer
Microsoft Word
Project Plans
QA
Languages:
English
Read
Write
Speak
Minimum Degree Required: Bachelor's Degree

Posted By

Vaibhav Nashikkar

Dice Id : 10120850
Position Id : 2020-18304
Originally Posted : 1 month ago
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