Specialist IV, Batch Disposition

Description

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 an opportunity for all employees to collaborate internationally, offering visibility and the opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.

The Specialist IV, Batch Disposition is responsible for ensuring that batches manufactured by Contract Manufacturing Organizations (CMOs) and BI OPUs for products to be distributed in the US meet the following requirements prior to approval to distribute:

• the batch and manufacture comply with marketing authorization.
• manufacture was carried out in accordance with current Good Manufacturing Practices (cGMPs).
• manufacturing and testing processes are completed according to specifications.
• ensure products are manufactured in accordance with Quality Assurance Agreements (QAAs) as required.
• discrepancies have been resolved/closed.
• verified required disposition documentation has been received and is complete.

The Specialist IV, Batch Disposition is 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. This role is responsible for escalating any unresolved non-standard events to Quality Management (Commercial & 3PQM) in a timely manner to prevent disruption within the supply chain.

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 to distribute, reject) decisions and address non-standard events and documentation errors with CMOs. Errors in decision making can result in market action such as product recall and/or interruption in the supply chain, therefore ability to meet the market demands.
• 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 or BI OPU to ensure quality of documentation is provided Right First Time and obtain resolution/commitments from involved CMO prior to batch disposition.
• 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 the SAP transactions associated with the batch disposition.
• Performs additional duties as assigned.

Requirements

• BS/BA in Chemistry, Pharma, or related science with minimum five (5) years’ experience in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
• Diploma with minimum seven (7) years’ experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
• Registered Pharmacist preferred.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.