QA-QC Inspector II - Collins Consulting Inc
Branchburg, NJ 08876
About the Job
This is an onsite position in Branchburg, NJ, local candidates only.
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)
Top 5 Skills/Experience/Education required for this position:
1. Associate or Bachelors preferred
2. Detail oriented
3. GMP experience preferred
4. Critical thinking
5. Effective Communicator
Work Schedule:
" Work schedule Monday-Friday 730AM-4PM
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)
Top 5 Skills/Experience/Education required for this position:
1. Associate or Bachelors preferred
2. Detail oriented
3. GMP experience preferred
4. Critical thinking
5. Effective Communicator
Work Schedule:
" Work schedule Monday-Friday 730AM-4PM
Source : Collins Consulting Inc