BATCH RECORDS AUDITOR 1st Shift (Fri/Sat/Sun/Mon)

Responsible for the timely review of all finished product batch records and related documents to ensure compliance with cGMP, SOP, and FDA regulations and release deadlines. To provide recommendations, resolution and take appropriate action to ensure compliance.

This position reports to the MQA Supervisor and works closely with Operations to analyze and recommend corrective action for successful compliance of batch records and related documents. The position requires daily interaction with direct supervision and other departments or facility personnel. Required to function as a "team" member to aid in reaching department and facility goal(s).

• Audits all incoming batch record documentation, including all production, validation, stability, and clinical lots to meet release deadlines.
• Analyzes and recommends corrective action needed for successful compliance of batch records and related documentation.
• Performs weekly Work In Progress (WIP) responsibilities including the collation and presentation of information relating to the status of all batches.
• Prepares the Certificate of Analysis for product batches.
• Maintains multiple Hold, Sample Requisition, and Investigations
• Initiates DCRs/CN revises and reviews SOPs as required for compliance with batch records.
• Supports management in identification of investigations and recommend resolution of issues/noncompliance.
• Coordinates System Release Documents and communicates outstanding requirements to appropriate departments.
• Complete applicable batch release requirements in SAP and LIMS.
• Coordinate and close out of cancelled batch records and prepared release batches for filing.
• Contributes to the organization and maintenance of the departmental office supplies.
• Performs other duties as assigned by Disposition Supervisor, Sr. QA Manager or Director of Quality.
• Complete assigned training in the Learning Management System

• High School Diploma or Equivalent
• Minimum 1 year previous relatable experience
• Detail oriented
• PC Skills
• Good knowledge of cGMPs
• Previous experience in a pharmaceutical environment a plus

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