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Documentation Specialist I

Company: CorTech LLC
Location: Fremont
Posted on: June 29, 2020

Job Description:

Duties
This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met.

Independently executes (paper/electronic) batch record review
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventor

Skills
Demonstrated proficiency in MS Office programs and associated computer programs.

--- Technical knowledge of manufacturing systems, methods and procedures.
--- Must have excellent written and verbal communication skills.

--- Awareness and understanding of Manufacturing processes

Education
.Requires a Bachelor's degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment.
--- In lieu of a Bachelor's degree, will consider an Associate's degree plus 4 years of professional experience in a GMP environment or clean room assembly environment.

Keywords: CorTech LLC, Fremont , Documentation Specialist I, Other , Fremont, California

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