Captek Softgel International

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QA PBR Reviewer

Captek has three Southern California facilities

EMPLOYMENT

QA PBR Reviewer

Cerritos Office

Essential Duties and Responsibilities:

  • Reconciles reviews, corrects, and approves executed production batch records (PBRs) in accordance with Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs).
  • Reviews the executed PBRs and supporting documentation to determine compliance with all written procedures and specifications.
  • Reviews GMP documents, which includes but not limited to Standard Operating Procedures, test data sheets, controlled forms, deviation records and other GMP related documents.
  • Coordinates review activities with personnel in Encapsulation, Compounding, Inspection, Packaging, Bottling, QC and QA.
  • Investigates discrepancies and ensures all issues are resolved.
  • Consolidates the PBRs and all associated supporting records into a batch file, and initiates and coordinates completion of documentation pertaining to product release.
  • Create, review and approve bulk and bottling case labels.
  • Assist with filing and maintenance of batch records.
  • Initiation of NCR investigations.
  • Performs other duties as assigned by QA Supervisor(s) and Lead(s).

Educational Qualification: 

  • Minimum High School Diploma, AA or higher degree preferred.
  • Working knowledge of ISO, cGMP or FDA regulations as it pertains to document control.
  • General proficiency in using Microsoft Office.

Required Skills / Experience: 

  • Experience working in a pharmaceutical, OTC, medical device, cosmetic product or food manufacturing facility a plus.
  • Prior experience with technical writing a plus.
  • Must be able to read and write English, perform mathematical calculations, follow instructions, attention to detail, multi-task, and handle multiple priorities without undue stress or errors.
  • Must be able to manage projects and schedules, meeting milestones and timelines.
  • Must be able to interact with others in a diplomatic and assertive manner while maintaining a teamwork attitude.
  • Good verbal and written communication skills.
  • Must be able to work in a fast-paced environment.

To apply:

If you are interested in this position, please apply here.