Specialist, QC Lab General, Onsite, Fremont CA

Boehringer Ingelheim; Fremont (CA); Presencial; USD 88.000 - 132.000; Jornada completa

Descripción de la vacante

Boehringer Ingelheim in Fremont, CA is seeking a QC/Analytical Scientist to oversee analytical testing of bulk drug substances and products in a multi‑product facility. You will lead method transfers, validate assays, and provide technical reviews within cGMP.

The role emphasizes quality, compliance, and continuous improvement, with opportunities to contribute during audits and to develop SOPs while collaborating across cross‑functional teams.

Formación

• BS/BA or MS/MA in a science or engineering field with relevant analytical testing experience.
• Experience with technical review, data analysis, and interpretation of scientific results.
• Familiarity with GMP/cGMP and quality system processes (SOPs, deviations, CAPAs).

Responsabilidades

• Provide technical oversight and review QC analytical testing in a multi‑product facility.
• Lead routine method transfers, validations, and qualification activities as SME.
• Identify improvements to lab processes and ensure compliance with GMP.
• Document work according to cGMP and cGDP; maintain training and group trainings as SME.

Conocimientos

Technical analysis

GMP knowledge

Auditing liaison

Data interpretation

Quality systems

Educación

BS/BA in science or engineering

MS/MA in science or engineering

Herramientas

Computer-based systems

Descripción del empleo

Compensation Details

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:

• Medical


• Dental


• Vision coverage


• Retirement savings opportunities


• Paid time off


• Paid holidays


• Disability and life insurance benefits


• Other company‑sponsored benefits

Description

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 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.

Duties & Responsibilities

• 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.


• 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.


• Establishes lab areas according to predefined standards (5s). Group representative on simple or routine equipment qualifications. Managing projects of core or platform within Quality.


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


• Leads OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place. Manages deviation investigations as applicable and provides product quality impact assessment. Ensures deviations assigned are promptly closed. Responsible for training others.


• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Influences and leads inter‑departmental meetings with cross‑functional team members to resolve issues and produce solutions.

This role is not lab focused. It will prioritise the following:

• Change Control, Deviation, CAPA and Action owner


• Updates to testing specifications and SOPs


• Monitoring timely release (e.g., incoming materials) and various QC metrics


• QC DRD representative for cross‑functional projects


• Authors/updates specifications, SOP, and other GMP‑related documents


• Owns Change Control, Deviations, CAPAs, Impact Assessments, etc.


• Follows‑up with appropriate areas to ensure target dates are met.


• Owns and/or leads projects (e.g., process improvement, CAPA, etc.)

Requirements

• BS/BA from an accredited institution in a science or engineering related field, with four (4) years of work experience in analytical testing in a GMP regulated industry or equivalent; Or


• MS/MA from an accredited institution in a science or engineering related field, with two (2) years of work experience in Analytical testing in a GMP regulated industry or equivalent.


• Proven experience with technical review, analysis and interpretation of scientific data.


• Experience with computer‑based systems and ideally experience with process control systems.


• Previous experience authoring SOPs, methods, and/or work instructions.


• Experience interacting with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise.


• Experience troubleshooting technical problems and/or equipment.


• Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.


• Expert in analytical methods, execute critical decision making, work independently with very little supervision, champions problem resolution, knows when to elevate to upper management, and provides compliant and smart solutions for complex validation issues.


• Expert understanding of analytical methods and validation principles in pharmaceutical / biopharmaceutical / medical device industries.


• Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.


• Track record of troubleshooting and applying the scientific method to solve technical problems.


• Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.).


• Ability to work as part of a high performing team and collaborate effectively with staff.


• Demonstrated ability to lead projects of low complexity.

Desired Skills, Experience and Abilities

• Experience in quality and cGMP environment. Knowledgeable in deviations, change control, and CAPAs.


• Pharmacopeial knowledge (e.g., USP, Ph. Eur), ICH.


• Problem‑solving capabilities (e.g., analytical, recognizes data trends, etc.).


• Detail oriented with a right first time mindset.


• Communication and collaboration skills. Works with cross‑functional teams.


• Open to change and drives improvements/efficiencies.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long‑term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com