BATCH RECORD REVIEW ASSOC

Allentown, PA 18104 | Direct Hire

Post Date: 03/09/2018 Job ID: BRRA - TB Industry: Medical Manufacturing Branch: Pay Rate: $20-$40 PER HOURS

 

  • 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:

  1. Experience in Pharmaceutical or related industry is preferred
  2. Knowledge of FDA regulations related to cGMPs required.
  3. Knowledge of cGDPs required
  4. Knowledge of quality control/ assurance required
  5. Knowledge of DEA regulations preferred

                                                                                                                                               ONLY SERIOUS APPLICANTS NEED TO APPLY

                                                                                                                        SEND RESUMES ALONG WITH SALARY REQUIREMENTS TO TBRADLEY@ATWORK.COM

 

 

Cathi Brown
Senior Account Representative


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