QA PBR Reviewer

CAPTEK Softgel International • Vista, CA

1d • Onsite

About The Position

It is the responsibility of the QA department Production Batch Record Reviewer to review batch records, RedZone entries in preparation for QA disposition of the product.

Requirements

• 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.
• Experience working in a pharmaceutical, OTC, medical device, cosmetic product, or food manufacturing facility is a plus.
• Prior experience with technical writing is a plus.
• Must be able to read and write English, perform mathematical calculations, follow instructions, attention to detail, multi­task, 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 diplomatically and assertively while maintaining a teamwork attitude.
• Good verbal and written communication skills.
• Must be able to work in a fast-paced environment.
• A good understanding of ERP systems.

Responsibilities

• Reviews and reconciles, production batch records (PBRs) per 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 for adherence to cGMP, Good Document practices (GDP), HACCP, and Food Safety that includes but are 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, Maintenance, and QC.
• Investigates discrepancies and ensures all issues are resolved.
• Consolidates the PBRs and all associated supporting records into a batch file, initiates and coordinates completion of documentation pertaining to product release.
• Create, review, and approve bulk and bottling case labels.
• Files and maintains batch records.
• Initiates NCR and deviation investigations when necessary.
• Performs other duties as assigned by QA Supervisor(s) and Lead(s).
• Ability to multi task under time constraints.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED