Senior Specialist / Principal Specialist, Investigation

About the role

Conducts investigations into complex and abstract deviation events for products produced at BIAH. 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 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.

Responsibilities

• Performs the investigation of deviations for somewhat complex products manufactured at BIAH to identify the root cause, impact assessment, and CAPA to assess quality requirements to comply with USDA, EU, FDA, or other GMP regulatory requirements and proposes disposition of the product.
• May be assigned to or assist with investigational reports not associated with local deviations such as TPMQ, complaint, or other facility investigations.
• Participates on investigation-related project teams to evaluate events which are investigated.
• Completes maintenance of systems associated with the investigation function.
• Produces the technical investigation report detailing the findings and assessment of the investigation under some direct supervision. Investigation reports and impact assessments are complete and compliant with regulations.
• Submits data for weekly/monthly KPI reports.
• Serves as lead QA representative and SME on assigned internal and external project teams (change controls, process improvements, technology transfer, training, business process excellence, electronic system deployment) as a technical/compliance resource to solve quality-related issues.
• Communicates new requirements/performs training with the QA Investigation team to assure all timelines are met, resulting in successful project completion and new product launches.
• Assists with internal, regulatory, or corporate audits to ensure compliance with domestic and international regulations, quality requirements, and guidance documents. Assists with audit responses and completion of assigned CAPAs by target due dates. Ensures QA Investigation areas are 'inspection ready' at all times.
• Influences as a technical resource and departmental SME for quality-related questions or topics including Regulatory, Corporate, and Site-Specific requirements.
• Performs all company business in accordance with all regulations (e.g., GMP, USDA, FDA, EU) and Company policy and procedures. Demonstrates high ethical and professional standards with all business contacts to maintain BIAH's excellent reputation in the community. Reports any violations noted or observed immediately to management.
• Serves as a deputy to the QA Investigations Leader in the event of his/her absence.

Requirements

• A BS degree from an accredited institution in a relevant scientific discipline plus eight (8) years of relevant experience OR an MS degree from an accredited institution in a relevant scientific discipline plus five (5) years of relevant experience OR a PhD from an accredited institution in a relevant scientific discipline plus three (3) years of relevant experience is required. Relevant BIVI experience may be weighted more significantly.
• Influencing technical writing skills to provide complete, timely investigation reports.
• Demonstrated logical skills with excellence in written and verbal communication.
• Theoretical and practical knowledge of regulated processes and technical disciplines such as root cause analysis, sterilization, aseptic processing, QC testing, quality and compliance, production excellence, and/or maintenance services.
• Able to select, develop, and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by BIAH.
• Demonstrated ability to lead and influence large projects and teams.
• Ability to make and influence decisions with minimal supervision regarding the acceptability of product based on the investigation provided.
• Technically self-sufficient and proficient in the performance of investigations including root cause analysis, impact assessment, CAPA development, and effectiveness of CAPA plans.
• Excellent attention to detail.
• Ability to utilize computer programs such as Microsoft Suite, SAP, IDEA for CON, Learning One Source, TrackWise, and other relevant electronic applications.

Physical Demands / Surroundings

• Lifting, pushing, pulling, and/or carrying less than 25 pounds occasionally.
• Constant periods of sitting.
• Frequent standing, walking, or climbing stairs.
• Crouching/squatting, bending/stooping, twisting, above-the-shoulder or low-level work, fine finger dexterity/including grasping required occasionally.
• Writing and typing constantly.

Visual / Hearing Demands

• Color vision required.
• May require extended hours at a computer screen.
• Must be able to read electronic documents of all types.
• May be required to travel nationally.
• Must be able to pass a background investigation, including verification of past employment, criminal history, and educational background.

Desired Skills, Experience, and Abilities

We value a workplace that embraces differences as strengths and encourages innovation. As part of our team, you will help drive meaningful change to improve millions of lives. We offer programs and groups focused on health and wellbeing, alongside opportunities for career development in a respectful and inclusive environment where everyone is valued.