BATCH RECORDS AUDITOR

Job Summary

The Batch Record Auditor is responsible for the accurate and timely audit/ review of finished product for commercial distribution. Ensures good record keeping of all manufacturing related documentations. Provides log of corrections and support to department during training. Reviews batch records for timeliness and accuracy. Performs final review of manufacturing documentation and provides support in areas for compliance.Responsibilities

PRINCIPAL ACTIVITES PERFORMED BY THE INCUMBENT

 Obtain the QA document control issued batch records and provide them to the manufacturing team for execution. Ensure that the manufacturing team has the required batch records to adhere with the production schedule. Manage the review of batch records for all manufacturing areas (real time and post execution). This review will encompass a review for GDP, ensuring the accuracy of steps being documented/performed, and a verification of SAP consumptions of materials against the pick list. Perform SAP consumption corrections as needed. Obtain the QA issued logbooks and provide them to the manufacturing team for use. Manage the review of logbooks upon manufacturing use. This review will encompass a review for GDP and ensuring the accuracy of steps being documented/performed. Request new logbooks as needed. Communicate to management the identification of deviations in batch records and/or logbooks before submitting to QA for final review. This will support Management in identification of deviations. Evaluate operators’ documentation errors, communicate results to the department supervisor, and provide guidance and training. Analyzes and recommends corrective action needed for document updates to promote continuous improvement.

 Manages, mentors and coaches 4 or more employees. Has hiring, firing and performance decision power

 Manages, mentors and coaches less than 3 employees. Has hiring, firing and performance decision power

 Manages, mentors and coaches other employees. Does NOT have hiring, firing and performance decision power

 Does NOT manage other employees. Does NOT have hiring, firing and performance decision power

• High School Diploma with 3+ years of pharmaceutical experience.
• Proficient skills in Microsoft Word, Excel, Document Quality Management System, SAP, and Trackwise.
• Knowledge of the Code of Federal Regulations Parts 210 and 211 relative to the processing of parenteral drug products.
• Strong oral and written communication skills required.
• Ability to work independently, set priorities and handle multiple tasks/ projects simultaneously. v

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.