Specialist, QC Lab General, Onsite, Fremont CA

The base salary range for this position is $88,000 to $132,000. 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.

Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, or Raw Materials/Cleaning validation/verification. Provides technical oversight, coordinates and reviews analytical testing of bulk drug substance and drug product in a multi-product facility. 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 maintenance activities. Identifies and implements fundamental improvements to lab processes and compliance activities. Responsible for quality and compliance activities (new test methods, specs, plans, reports, forms, SOPs) that are new or non-routine.

Performs duties under limited supervision and according to standard operating and QC procedures. Group representative on simple or routine equipment qualifications. Serves as QC subject matter expert (SME) representing the department during audits for 3-5 topics within group. Technical and Quality lead for for routine or platform method transfer/validations/qualifications, verifications and technical assessments. Executes with oversight moderately complex QC related compliance deliverables within different areas of the Quality System (deviations, investigations, OOS and CAPAs and change controls).

Managing projects of core, platform processes within Quality.

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.

• Provides technical oversight, coordinates and reviews QC analytical testing of bulk drug substance and drug product in a multi-product facility. SME in 3-5 analytical methodologies within different scientific principles. Technical and Quality Lead for routine or platform method transfer/validations/qualifications, verifications and technical assessments.
• Identifies and implements new improvements to lab processes and compliance activities. Responsible for quality and compliance activities (new test methods, specs, plans, reports, forms, SOPs) that are new or non-routine. Executes with oversight new, multi-faceted QC related compliance deliverables within different areas of the Quality System (deviations, investigations, OOS and CAPAs and change controls). Serves as QC subject matter expert (SME) representing the department during audits for 3-5 core within group.
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