Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is a global leader in the pharmaceutical industry, and they are seeking a Senior Specialist in QA Complaints to manage product quality and ADE complaints for their biological products. This role involves ensuring compliance with regulations, conducting investigations, and providing guidance on complaint handling processes.
Responsibilities
• Responsible for maintaining compliance with FDA/EU/USDA regulation in the area of product quality complaints. As the primary and initial QA contact for receiving all product quality complaints, this individual will gather all available information from all sources and make an initial assessment of severity of all complaints received
• Will initiate, conduct investigation to include batch record, retain, stability sample review etc and report summary conclusion and findings for every complaint. Will track return samples and coordinate sample testing. Will provide guidance and support to all groups dealing with complaint handling life cycle, complaint related SOP´s and Trackwise questions
• Incumbent will assist with OOS´s and assign investigation, review investigations and summarize the investigation as well as disposition the product in question in a timely manner
• Will generate and or improve processes to enhance and maximize resource utilization
• Will review related temperature excursions for products shipment and perform appropriate investigations and recommend appropriate disposition
• Assign investigations and CAPAs to logistics and impacted departments and follow up on the CAPAs
• Assist with trend analysis and report the analysis to management as appropriate and monthly KPI tracking for complaints
• Provide input to improve processes to enhance and maximize resource utilization
• Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH´s excellent reputation in the community
Skills
• Minimum of a BS degree from an accredited institution, with five-plus (5+) years of business experience; or MS degree from an accredited institution in a relevant scientific field, with three-plus (3+) years of relevant business experience; or a PhD from an accredited institution in a relevant scientific discipline
• Work experience in USDA or European Union (EU) regulated animal health industry required
• Good written and communication skills, strong investigative skills required as the position involves investigation involving various products and various departments
• Requires knowledge of vaccine products, manufacturing procedure and processes
• Has sound decision making skills along with ability to take quick actions and excellent attention to detail
• Requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications
• Demonstrated understanding of GMP´s, root cause analysis, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality decisions
Company Overview
• Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is https://www.boehringer-ingelheim.com/.
Company H1B Sponsorship
• Boehringer Ingelheim has a track record of offering H1B sponsorships, with 13 in 2025, 4 in 2024, 11 in 2023, 7 in 2022, 17 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.