QA PBR Reviewer
QA PBR Reviewer
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).
- 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.
If you are interested in this position, please apply here.