Current Job Openings
PTS Advance is looking to speak with Quality professionals to join our client, a medical device manufacturer, in the Fort Lauderdale, FL area as a QC Document Reviewer.
In this role, you will support Operations and Development by reviewing documentation within the QC department - material inspection files, in-process inspection, testing data review, and Batch Record documentation review.
Main Responsibilities
- Review incoming material inspection files, in-process inspection, testing, and manufacturing batch records documentation to assure that the documentation is complete, correct, and in compliance with specification and regulation requirements prior to final disposition.
- Report any discrepancies found during the review that could compromise the product quality.
- Responsible for reporting any abnormal conditions and enforcing all GMP, quality, safety, and security rules.
- Performs product identification and traceability activities as required (e.g., Quarantine).
- Notifies management of nonconforming material or test failures in a timely manner.
- Segregates nonconforming materials per applicable procedures.
- Assists with the initiations and updates to QMS documents like procedures, work instructions, forms, technical documents, etc.
- Assists in resolving issues on the manufacturing floor, incoming material inspections as well as QC testing.
- Authors and supports documentation for events, NCRs, CAPAs, and Out of Specifications documents.
- Complies with all quality, safety, and work rules and regulations.
Skills and Qualifications
- 2 years in the pharmaceutical and/or medical device industry or equivalent with knowledge and experience conducting documentation reviews.
- Testing and Laboratory documentation review experience preferred.
- Associate Degree in Science or related area (equivalent experience will be considered).
- Knowledge of Good Documentation Practices.
- Knowledge of Good Manufacturing Practices.
- Proficient in the use of Microsoft Products (Word, Teams, Excel).
If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance
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