Batch Record Reviewer II

Fremont, California

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Type: Contract

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 293435

Date Posted: 11/23/2022

Start Date: 12/12/2022

End Date: 06/09/2023

Shortcut: http://jobs.systemoneservices.com/kgp5Fx


Title of Position: Batch Record Reviewer II

6 month contract
On site 94555

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.
  • The position performs logistical duties related to batch record review.
  • 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) inventory.

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 Bachelors 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 environment or clean room assembly environment.

Skills:  

Required

GMP
BATCH RECORD REVIEW
MANUFACTURING PROCESSES
EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
DOCUMENTATION
CLEAN ROOM

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


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