SR Specialist, QC Lab General, Fremont CA

About the role

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. Performs duties under limited supervision and according to standard operating and QC procedures. This role serves as a technical and quality lead for non-routine, new method transfer, validations, qualifications, verifications, and technical assessments, with responsibility for quality and compliance activities across the Quality System.

Responsibilities

• Technical and Quality lead for non-routine, new method transfer, validations, qualifications, verifications, and technical assessments.
• Group representative on equipment qualifications for new and novel technology.
• Team lead responsible for quality risk assessment, onboarding, qualification, and implementation of non-routine, new method equipment validation.
• Identifies and implements novel improvements and new ways of thinking toward lab processes and compliance activities.
• Responsible for quality and compliance activities including new test methods, specifications, plans, reports, forms, and SOPs with no previous experience within the department.
• Cross-functional project team lead for complex QC-related compliance deliverables (deviations, investigations, OOS, CAPAs, and change controls) impacting multiple functional areas in the QC department.
• Serves as a QC subject matter expert (SME) representing the department during audits for critical processes.
• Documents work according to cGMP and cGDP; adheres to established regulations and reports abnormalities/deviations in a timely manner.
• Adheres to safety standards and escalates unsafe situations appropriately.
• Represents the team on global initiatives and external-facing client teams.
• Project leader for non-routine, new initiatives with local cross-functional impact.
• Establishes timelines, sets goals, and implements strategy for site-wide QC projects.
• Maintains compliance training and trains other technicians and associates on operations and complex topics.
• Establishes training curricula and trains others as an SME; implements new training procedures and drives continuous improvement.
• Leads OOX and OOE investigations; identifies protocol discrepancies and ensures proper root-cause analysis.
• Responsible for technical review, interpretation, trending, and investigation of atypical results.
• Influences and leads inter-departmental meetings to resolve issues and produce solutions.
• Manages deviation investigations and provides product quality impact assessments.
• Leads complex deviation investigations and provides product quality impact assessments.

Requirements

• Bachelor’s Degree in a science or engineering-related field with six (6) years of experience in analytical testing in a GMP-regulated industry; or
• Master’s Degree in a science or engineering-related field with four (4) years of experience in analytical testing in a GMP-regulated industry; or
• PhD in a science or engineering-related field with two (2) years of experience in analytical testing in a GMP-regulated industry (PhD preferred).
• Proven experience with technical review, analysis, and interpretation of scientific data.
• Experience with computer-based systems and process control systems.
• Previous experience authoring SOPs, methods, and/or work instructions.
• Experience providing oral and poster presentations on complex technical problems.
• Subject matter expert in analytical methodologies relevant to biopharmaceutical manufacturing.
• Expert understanding of analytical methods and validation principles in pharmaceutical/biopharmaceutical/medical device industries.
• Ability to work independently with minimal supervision, champion problem resolution, and escalate to upper management when necessary.
• Skills in Quality Systems (CAPA, Change Control, Deviations, OOX, etc.).
• Ability to work as part of a high-performing team and collaborate effectively.
• Ability to interact with auditors and regulators, clearly communicate subject matter expertise, and solve complex technical problems independently.
• Demonstrated ability to lead cross-functional projects of moderate complexity.
• Proven track record to mentor, train, and lead others within the discipline.

Desired Skills and Experience

• Strong knowledge of GMP regulations, data integrity principles, investigations, CAPA management, Change Controls, and inspection readiness.
• Demonstrated experience leading complex investigations and cross-functional projects.
• Excellent technical writing, communication, and organizational skills.
• Ability to influence stakeholders and drive projects to completion in a fast-paced environment.
• Experience with quality systems such as TrackWise or similar electronic quality management systems (preferred).
• Knowledge of microbiology, aseptic manufacturing, environmental monitoring, and contamination control strategies (highly desirable).
• Ensures compliance and quality oversight of QC records, data integrity controls, and documentation practices.
• Supports audit and inspection readiness activities, including preparation, response management, and follow-up actions.
• Authors and reviews trend reports, compliance metrics, and quality assessments.

Pay

This position offers a base salary typically between $75,000 and $122,000. The position may be eligible for a role-specific discretionary bonus, relocation, and/or other compensation elements. Actual compensation will be based on job-related factors such as skills, experience, and qualifications.

Benefits

Boehringer Ingelheim supports employees with competitive compensation and benefit programs, including health and wellbeing initiatives, global accessibility to healthcare, and programs fostering career development. For an overview of benefits, visit Boehringer Ingelheim’s benefits page.