Quality Assurance Quality Control

4 weeks ago


Branchburg Township, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • 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)

Qualifications:

  • Associate or Bachelors preferred

  • Detail oriented

  • GMP experience preferred

  • Critical thinking skills

  • Effective Communicator

  • Work schedule Monday-Friday 730AM-4PM



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