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- Review processing batch records for compliance with all specified requirements and procedures.
- Make final determination regarding suitability of LifeCell products for final release of a lot to Finished Goods and/or other dispositions, including rejections.
- Work closely with Manufacturing and Quality to resolve any discrepancies uncovered during batch records review.
- Generate Certificate of Conformances as deemed necessary.
- Initiate reworks when applicable for nonconforming product to ensure they are conforming
- Quarantine product as deemed necessary for identified non-conforming product.
- Complete transactions as deemed necessary for acceptable or non-conforming product.
- Compile and perform trending of issues encountered at batch record review to identify any drift in performance or potential issues.
- Confirm research consent for lots designated for marketing, research or validation purposes
- Investigate Non-conformance's and CAPA's.
- Assist Supervisor with various projects and metrics as deemed necessary.
- Initiate change controls for the department. (ECO's)
- Associate or Bachelors preferred
- Detail oriented
- GMP experience preferred
- Critical thinking
- Effective Communicator
Quality Assurance Quality Control - Branchburg, United States - Spectraforce Technologies
Description
Job Title:
Quality Assurance Quality Control (QA-QC) Inspector
Job Duration: 06 Months with possible extension
Job Location:
Branchburg, NJ, 08876
Work Schedule:
Work schedule Monday-Friday 730AM-4PM.
Position Purpose:
Top 5 Skills/Experience/Education required for this position: