US_ Master QC Associate, QC Lab General

Boehringer Ingelheim; Fremont (CA); On-site; USD 56,000 - 96,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement

Paid time off

Paid holidays

Disability insurance

Life insurance

Job summary

Boehringer Ingelheim Fremont is seeking a QC professional to execute analytical testing of bulk substance and drug product in a multi-product facility. The role covers method transfer, raw material sampling, and supporting compliance activities under cGMP.

You will serve as SME, participate in audits, review data, and help train others. A science degree and hands-on laboratory experience in regulated environments are required, with a focus on accuracy and attention to detail.

Qualifications

• SME in 3–5 analytical methodologies across scientific principles.
• Experience with quality reviews, trending, and investigations.
• Knowledge of cGMP/GDP and regulatory expectations.

Responsibilities

• Execute non-routine analytical testing methods under supervision.
• Perform technical review, interpretation, and investigation of atypical results.
• Coordinate method transfer/validation activities and CAPAs as needed.
• Train others as SME and support audits.

Skills

Analytical testing

cGMP knowledge

Quality review & investigations

SME in analytical methods

Education

Bachelor’s degree in science or engineering

Associate degree with cGMP experience

Master’s degree in science/engineering

Job description

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 click here .

Compensation Details

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 click here .

Description

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.

Duties & Responsibilities

• 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. Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions. Ensures deviations assigned are promptly closed.
• Responsible for training others
• Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment. Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance

Senior QC Requirements

• High School Diploma with six (6) years’ experience of experience in cGMP regulated industry or equivalent
• Associate Degree with four (4) years’ experience of experience in cGMP regulated industry or equivalent
• Bachelor’s Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent
• Previous QC Experience preferred
• Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset
• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
• Proven experience with technical review, analysis, and interpretation of scientific data
• Strong written and verbal communication skills
• Experience with computer-based systems and ideally experience with process control systems
• Previous experience to read and understand SOPs and/or methods and document work in a written format applying cGMP/GDP standards
• Ability to work as part of a high performing team and collaborate effectively with staff
• Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed
• Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
• Strong focus on execution of non-routine analytical methods or processes
• Strong technical knowledge in analytical methods
• Ability to work independently with very little supervision
• Champions problem resolution
• Knows when to escal…?

Master QC Requirements

• Bachelors degree from an accredited institution in a science or engineering related field, with four (4) years of experience in cGMP regulated industry or equivalent; Or
• Masters degree from an accredited institution in a science or engineering related field, with one (1) years of experience in cGMP 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 and document work in a written format applying cGMP/GDP standards
• Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing
• 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 tosolve technical problems
• Strong written and verbal communication skills
• Ability to work as part of a high performing team and collaborate effectively with staff
• Clearly understand subject matter and concisely communicate within areas of subject matter expertise
• Audit experience preferred
• Strong technical knowledge in analytical methods.
• Work independently with very little supervision, champions problem resolution, knows when to escal…? and provides compliant and smart solutions for moderately complex method and testing issues.

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