US_ Master QC Associate, QC Lab General

The base salary range for this position is $55,500 to $83,300 OR $64,200 to $96,400. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, qualifications, and other factors permitted by law.

Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please  ().

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing. Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility. Execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable). SME in 3-5 analytical methodologies within different scientific principles.

Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Coordinates routine maintained activities. Responsible for quality and compliance activities (authoring of non-routine test methods, specs, plans, reports, forms, SOPs) of moderate complexity. Performs duties under limited supervision and according to standard operating and QC procedures. Serves as QC subject matter expert (SME) representing the department during audits for core topics within group.

Performs analytical testing for method transfer/validations/qualifications, verifications and technical assessments. May be responsible for one or more QC related compliance (deviations or OOS or CAPAs or CCs) deliverables for routine or core processes. Trains others as a SME. 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.

• Executes independently with adequate training non-routine analytical testing methods. SME in 3-5 analytical methodologies within different scientific principles. Performs investigational testing and troubleshooting of analytical methods.

• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Identifies and implements new improvements to lab processes compliance activities. Responsible for quality and compliance activities (authoring of test methods, forms, SOPs) that are non-routine. Manages and reviews fundamental tasks such as but not limited to: buffer prep, TCU maintenance, and cleaning.

• Serves as QC subject matter expert (SME) representing the department during audits for core topics within group. Performs analytical testing for method transfer/validations/qualifications, verifications and technical assessments. Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner.

• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.

• Maintains and improve lab areas according to predefined standards (5s).

• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on compliance topics and scientific principles. Establishes training curricula and train others as a SME.

• Supports OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place.…