BATCH RECORD REVIEW ASSOC
Allentown, PA 18104 | Direct Hire
- Review of line documentation related to contract packaging
- Follow up on customer inquiries as they relate to documentation and compliance issues
- Complete final review and release for product distribution
SALARY BASED ON EXPERIENCE $20-$40 PER HOUR
DUTIES AND RESPONSIBILITIES
- Review of documentation related to primary, secondary and clinical packaging after completion of reconciliation
- Critical review and logging of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications and internal SOP's
- Follow-up on ALL customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product
- Final release of work in-process or finished product
- Logging and maintaining packaging process samples as well as coordinating shipment of samples to customers.
- Participate in internal, customer and regulatory audits at the discretion of senior management.
REQUIRED EDUCATION / EXPERIENCE:
- Experience in Pharmaceutical or related industry is preferred
- Knowledge of FDA regulations related to cGMPs required.
- Knowledge of cGDPs required
- Knowledge of quality control/ assurance required
- Knowledge of DEA regulations preferred
ONLY SERIOUS APPLICANTS NEED TO APPLY
SEND RESUMES ALONG WITH SALARY REQUIREMENTS TO TBRADLEY@ATWORK.COM