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Description
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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Specialist II, QA Complaints will ensure quality and compliance to regulations with respect to complaint investigations and anti-counterfeiting. The position holder is responsible for the investigation and accurate documentation of product complaint investigations resulting in confirmation of complaint or refute, while identifying appropriate Corrective Action Preventive Action (CAPA) and any further action required for the ensure product quality is obtained.
Duties & Responsibilities
Completes and provides complaint sample handling (i.e. laboratory testing for potential counterfeit complaints or processing of complaint samples), ensuring BI quality standards are maintained. Resolves gaps in quality standards when observed.
Monitors outsourced call center activities associated with complaint intake.
Collaborates on the call center oversight to improve quality and ensure compliance with regulations.
Provides feedback and recommendations on outsourced activities to ensure compliance with regulations and BIs quality standards.
Provides direction on how to close identified gaps.
Assists and completes investigations related to medical devices and future launch activities.
Establishes anti-counterfeiting measures by qualifying equipment.
Performs additional duties as assigned.
Responsible for setup of procedures and processes related to complaint sample handling for physical analysis (i.e. Raman). Writes/revises procedures:
Accurately captures steps needed to complete a task.
Ensures tasks result in compliance with regulations.
Edits and routes via current process/current system.
Updates/revises procedures as tasks change.
Ensures training is conducted to impacted colleagues.
Ensures market action documents are archived timely.
Facilitates meetings/discussions with impacted BI OPU or 3PQM representative that supports the impacted Contract Manufacturing Organization (CMO):
Discusses findings.
Develops and obtains CAPA commitment.
Verifies appropriate action taken to resolve complaint.
Processes Trends related to Risk Management:
Monitors trending.
Escalates identified trends to management, impacted 3PQM and impacted BI OPUs.
Evaluates risk management for complaint investigations.
Requirements
BS/BA in Chemistry, Pharmacy, or related science. A degree in a non-scientific field would be considered if there is prior experience in pharmaceutical investigations.
In lieu of BA/BS, a minimum of five (5) years of pharmaceutical industry experience with knowledge of production and quality orientation required.
Minimum three (3) years of pharmaceutical experience (or equivalent).
Demonstrated knowledge of investigation or troubleshooting skills, ability to identify root cause and assign corrective and preventative actions.
Demonstrated proficiency at facilitating and leading effective teams.
Demonstrated proficiency in communication skills both verbal and written.
Demonstrated technical writing skill.
Flexibility to changing work environment and deliverables.
Standard business computer skills, MS Word, MS Excel, etc. as required.
Attention to detail/quality mindset.
Eligibility Requirements :
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Desired Skills, Experience and Abilities
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.