Quality Assurance Specialist - Complaints

Quality Assurance Specialist - Complaints Description

The Quality Assurance Specialist (Complaints and Approval to Distribute) is a champion of accountability, agility, and intrapeneurship (AAI) behaviors and Quality Culture. This role ensures quality and compliance to regulations and internal procedures with respect to Complaint Handling and Approval to Distribute. The incumbent will assist as needed with Field Alert Reports (FARs), Biologic Product Deviation Reports (BPDRs), market actions, and Product Safety and Security.

This role 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 requirements for approval to distribute and also for escalating any critical events to Management in a timely manner.

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 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.

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

• Partners with Third Party Quality Management (3
  
  PQM), Contract Manufacturing Organizations (CMOs), and BI OPUs to ensure complaints are properly investigated and accurately documented within the global complaint system. Ensures the root cause or most probable root cause of reported complaint has been determined. Collaborates with BI OPUs, 3
  
  PQM, and CMOs as needed to review and recommend sustainable Corrective Action/Preventive Actions (CAPAs) to be implemented at impacted sites. Reviews, approves, or closes customer complaints ensuring that the investigation meets acceptable quality standards, including established timelines. Focus is on complaints with market action potential, while also supporting closure of other investigations as needed.
• Supports international Quality initiatives/projects. Acts as Local Pharmaceutical Complaint Officer (LPCO).
• Ensures that all complaints received at the local level are entered into the company's complaint system, categorized, and assigned to the appropriate investigation site within established timelines. Engages with the complainant, the Corporate Pharmaceutical Complaint Officer, and local health authorities. Performs regular complaint trending and generates complaint reports. Collaborates with other LPCOs and Deputy LPCOs on global continuous process improvement initiatives.
  
  Represents BIPI at internal and external forums on complaint management. Leads functional team meetings to keep critical events known to local Quality management. Provides complaint data to and participates in monthly cross‑functional Quality Management Review (QMR) meetings and 3
  
  PQM QMRs to ensure site awareness of complaints within US marketed products. Collaborates with others within Quality Assurance to maintain a high‑quality complaint process and adherence to established timelines. Actively participates in alignment calls with BIPI‑Ridgefield, HPSG, and Complaint MSO to drive continuous process improvement. Serves as local contact partner/liaison for Brand Safety & Security initiatives.
• Independently performs batch record review and/or final disposition of drug products manufactured by CMOs and BI OPUs to confirm compliance with specifications, cGMPS, and corporate policies and procedures.
• Possesses authority to make batch disposition (approval to distribute or reject) decisions and to address non‑standard events and documentation errors with CMOs. Errors in decision making can result in market action such as product recall or supply chain interruption; therefore, there must be ability…