QA PBR Reviewer

Summary 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. Essential Duties and Responsibilities Reviews and reconciles production batch records (PBRs) per SOPs, policies, and cGMPs. Reviews executed PBRs and supporting documentation to determine compliance with all written procedures and specifications. Reviews GMP documents for adherence to cGMP, GDP, HACCP, and Food Safety that includes but are not limited to SOPs, 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 PBRs and all associated supporting records into a batch file, initiates and coordinates completion of documentation pertaining to product release. Creates, reviews, and approves 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. Qualifications / Education 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. Skills / Experience 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. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. #J-18808-Ljbffr CAPTEK Softgel International