Batch Records Auditor (1st Shift)

Job description

Job Summary 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. This position works closely with Operations to analyze and recommend corrective action for successful compliance of batch records and related documents. Interact daily 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). Hourly Rate: $18.79/hour: Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Responsibilities: - 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 presen...