Check with seller Spec IV, Batch Disposition Columbus

  • Location: Columbus, Ohio, United States


This position is responsible for ensuring that batches of products to be distributed in the U.S. and manufactured by Contract Manufacturing Organizations (CMOs) or Boehringer Ingelheim Operating Units meet the following requirements prior to approval to distribute: 1) The batch and manufacturing comply with marketing authorization; 2) Manufacturing was carried out in accordance with current Good Manufacturing Practices (cGMPs); 3) Manufacturing and testing processes are completed according to specifications; 4) Products are manufactured in accordance with Quality Assurance Agreements (QAAs); 5) Deviations/investigations have been properly resolved/closed; 6) All checks and tests were performed including sampling, inspections and actions necessary as a result of deviations; 7) Production and quality control documentation has been completed and approved.

This position is also responsible for maintaining accuracy while effectively communicating critical details of non-standard events, partnering with 3PQM and involved CMO to resolve any non-standard events and escalating any unresolved non-standard events to Management and 3PQM Management in a timely manner to prevent disruption within the supply chain.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees

Duties & Responsibilities:
Independently performs batch record review and/or final disposition of drug products manufactured by CMOs and BI OPUs ensuring that the batch was produced in compliance with specifications, cGMPS and corporate policies and procedures.
Possesses the authority to make batch disposition (approval or, rejection of distribution) decisions and address non-standard events and documentation errors with CMOs.
Tracks and maintains Quality Metric data including batch disposition rate of CMOs and BI OPUs based on batch documentation reviewed and dispositioned.
Assesses Quality Metric for process improvements.
Partners with CMO to ensure quality and accuracy of documentation and obtain resolution/commitments from involved CMO prior to batch release.
Escalates, in a timely manner, unresolved non-compliance concerns and recommendations for resolution and quality trends to 3PQM and management to prevent supply chain interruption.
Prioritizes work to ensure no interruption to supply chain. First line of contact for escalation of potential problems with product or meeting market needs. Escalates to management any potential interruption to the supply chain when recognized.
Acts as a representative on cross-functional teams that require batch disposition input. Investigates and resolves inter-company deviations that impact batch prior to disposition.
Completes SAP transactions associated with the batch disposition.

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