What are the responsibilities and job description for the Quality Assurance Quality Control (QA-QC) Inspector II position at Collins Consulting Inc?
This is an onsite position.
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
