Specialist III, 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.

The Specialist III, 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.
• 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 III, 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. The position holder will escalate any unresolved non-standard events to Quality Management (Commercial & 3PQM) in a timely manner to prevent disruption within the supply chain.

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

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.
• Collaborates with Batch Disposition colleagues on process improvements; partners with CMO or BI OPU to ensure batch documentation meets established requirements.
• Escalates, in a timely manner, unresolved non-compliance concerns and recommendations for resolution and quality trends to Quality Management (Commercial & 3PQM) to prevent supply chain interruption.
• Prioritizes work to ensure no interruption to supply chain.
• Escalates to management potential interruption to the supply chain when recognized.
• Represents batch disposition in teams that require batch disposition input.
• Assists in investigations to resolve discrepancies 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 three (3) years’ experience within an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.

OR

• Diploma and five (5) 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.