Batch Record Reviewer (2nd Shift)

Responsibilities

Review of line documentation related to contract packaging, follow up on customer inquiries related to documentation and compliance, and complete final review and release for product distribution. The review process directly impacts company compliance with regulatory requirements and customer satisfaction.

• Responsible for review of documentation related to primary, secondary, and clinical packaging after completion of reconciliation.
• Responsible for critical review and logging of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications, and internal SOP’s.
• Responsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.
• Responsible for final release of work in-process or finished product.
• Responsible for reviewing and maintaining the QAD Item Master Maintenance and Router Maintenance.
• Responsible for logging and maintaining packaging process samples as well as coordinating shipment of samples to customers.
• Responsible for maintaining and filing of documentation related to packaging in current appropriate status locations.
• Responsible for entering lot specific information into the Quality Dashboard (Access Database).
• Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
• Other responsibilities as required.

Requirements

All employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.

Qualifications

• High School Degree required.
• One to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience preferred.
• Experience in pharmaceutical or related industry desired.
• General knowledge of FDA regulations related to cG