about 1 month ago
10 Dec 00:00
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.
- 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
- Pharmaceutical experience is required
- Minimum Bachelor’s Degree of Science
- This job offers benefits including paid time off (PTO) and medical after 90 days.