Description

Prepare accurate international quality release paperwork (e.g. APHIS Form 2008s, Manufacturer's Batch Protocols, Chinese Batch Records, CofA's) for all finished products in compliance with 9 CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. Maintain and retrieve information from Global Business Solutions (GBS) and other archived records as needed to support investigations and monthly. Use GBS to track and report status of product testing. Develop and implement process improvements within Quality Unit, across departments, and between animal health sites with particular care given to harmonization and regulatory compliance. Directly or indirectly responsible for supervision and leadership of support staff.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

• Analyze and approve Release paperwork for For Further Manufacture bulks and antigens in a timely manner.
• Process GBS reports of QC testing results and compile results to prepare release documentation for all BIAH and Third party testing sites.
• Review and lock results in GBS to make them ready for QA usage decisions.
• Track final product received in QC labs and monitor and update off-test dates in GBS to support Logistics, Planning and Marketing.
• Provide updates to serial testing issues and projected submissions in weekly production/planning meeting.
• Create weekly report to communicate status of filled serials.
• Review QC testing results and create APHIS Form 2008 for, Reprocess/Rework, Destruction and Pre-licensure of final product to support USDA disposition, CBRs (Chinese Batch Records) for China release, and MBPs (Manufacturer's Batch Protocol) for EU release and CofAs for Canada market release.
• Prepare Working seed certificates for EU.
• Create/Revise release documents as necessary.
• Review GBS QC testing results from Research and Development records, and Production batch records to create Manufacturers Research Documents to support registration of product.
• Review and approve QC and Third Party documentation to support release of Bulk and Antigen in-process samples to Production for final product.
• Update GBS status where applicable.
• Prepare documents to support product Packaging and Labeling at risk prior to release approvals. Distribute QC testing results from all BIAH sites, and Third-party testing results, to applicable BIAH personnel.
• Supply information to support Quality Assurance investigations, deviation, change controls and planned deviations.
• Troubleshoots and solves problems related to release documentation beyond method-defined action.
• Trains others on procedures.

Requirements

• Bachelor's degree in science from an accredited institution with a minimum of seven (7) years of experience in a vaccine production environment, with at least four (4) years in a quality position.
• Requires a fundamental working knowledge of scientific methods and regulatory requirements used to manufacture, test and evaluate biological products used in animals and for human consumption.
• Demonstrated knowledge and experience with regulatory requirements including, but not limited to 9 CFR, EU and VICH, and their and impact to projects and/or business.
• Able to manage minor projects independently and portions of major projects with supervision. Ability to manage resources and direct projects
• Makes routine decisions with limited guidance from supervisor.
• Working knowledge of GBS, Microsoft Office.
• Ability to work in a fast-paced environment.
• Ability to critically analyze data and draw appropriate conclusions, search for, implement solutions, and create new methodologies and procedures.
• Demonstrated ability to train others on routine procedures, lead and develop others and evaluate performance.
• Must be able to pass a background investigation, including verification of past employment, criminal history, and educational background
• Physical Demands / Surroundings:
  • Lifting – 25 pounds occasionally
  • Carrying 25 pounds occasionally
  • Pushing and pulling 25 pounds occasionally
  • May require extended periods of sitting, walking standing
  • Climb stairs, bending/stooping, crouching/squatting occasionally
  • Writing frequently
  • Periods of use of Personal Protective Equipment
• Visual / Hearing Demands:
  • Contact lenses are allowable.
  • May require extended hours at a computer screen.
  • Must be able to read electronic documents of all types.
  • Hearing acuity required
  • May be required to travel nationally.

Desired Skills, Experience and Abilities

PDN-9d24c3a2-f70a-4d91-8098-a9cf202ede49