Specialist, QC Lab General, Onsite, Fremont CA
Boehringer Ingelheim GmbH
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Benefits offered by this job
Job summary
BI Fremont in Fremont, CA seeks an experienced QC/Quality professional to provide technical oversight of analytical testing across multiple platforms, including method transfers and validations. The role emphasizes regulatory compliance, cGMP adherence, and senior-level review of data and investigations.
The position requires a strong background in GMP analytical testing, SOP authoring, cross-functional collaboration, and ability to lead improvement projects in a multi-product lab.
Qualifications
- BS/BA in a science or engineering field with four (4) years of work experience in analytical testing in a GMP regulated industry or equivalent.
- MS/MA 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 upscale 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.
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.
Skills
Education
Tools
Job description
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.
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.
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.)
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 upscale 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.
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.
38387
Quality, Manufacturing, operations & production
Experienced professionals
BI Fremont
Full-Time
On-Site
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. 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
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