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Documentation Specialist

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Documentation Specialist

Documentation Specialist

Middlesex, NJ

 

Join our client’s team as a Documentation Specialist!  This position is full time, contract to permanent, competitive pay with overtime.  This job offers benefits including paid time off (PTO) and medical after 90 days.

Responsibilities:

  • To maintain the PD/TS/R&D documentation records.
  • To guide documentation associates (if any) in the preparation of PD/TS/R&D documentation.
  • To maintain the PD/TS SOP’s.
  • Preparation of Exhibit Batch Manufacturing and Packaging Batch Records and Commercial Batch Manufacturing and Packaging batch Records.
  • Preparation of Exhibit batch qualification protocols, Product evaluation protocols and Process validation protocols.
  • Preparation of Development Reports and Process validation reports.
  • Preparation of change controls as per the requirement.
  • Support the PD/TS/R&D Scientist/Research Associates for documentation.
  • Perform other related duties as required and/or assigned

Qualifications:

  • Pharmaceutical experience is required
  • Minimum Bachelor’s Degree of Science

Benefits:

  • This job offers benefits including paid time off (PTO) and medical after 90 days.