SR Specialist, QA Complaints

Description

The basic purpose of this position is to provide investigation into product quality and ADE complaints for BIAH products. This individual will be responsible for maintaining compliance in the area of product quality complaint handling and for maintaining all aspects of the product quality business process for domestic and global biological products. This will include handling and disposition of all complaints received and temperature excursions that occur during shipping of biological products. Assist with investigation of OOS´s that occur. Assist in training new specialist as needed. This individual will be a resource for related technical and compliance information within the Quality and Compliance unit. 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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & 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.

Requirements

• 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.
• NOTE: Relevant BIAH experience may be weighted more significantly.
• 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.

Desired Skills, Experience and Abilities