What are the responsibilities and job description for the Batch Record Reviewer / QA Specialist (Batch Record/CAPA/Change Control) position at Systems Ally?
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:
- Associate or Bachelors preferred
- Detail oriented
- GMP experience preferred
- Critical thinking
- Effective Communicator
Job Type: Contract
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Associate (Preferred)
Experience:
- batch record review: 3 years (Preferred)
- CAPA: 3 years (Preferred)
- CGMP: 3 years (Preferred)
- Initiate change controls: 3 years (Preferred)
- Pharma or biotech or medical device or healthcare industry: 3 years (Preferred)
Ability to Commute:
- Branchburg, NJ 08853 (Required)
Work Location: In person
