Specialist, QC Lab General, Onsite, Fremont CA

Boehringer Ingelheim•Fremont, CA

8h•Onsite

About The Position

The Specialist, QC Lab General provides technical oversight and coordinates and reviews QC analytical testing of bulk drug substance and drug product in a multi-product facility. The employee serves as a subject matter expert in 3–5 analytical methodologies involving different scientific principles and leads routine or platform method transfers, validations, qualifications, verifications, and technical assessments. The role includes technical review, interpretation, trending, quality review, and investigation of atypical results, as well as routine equipment qualification representation and coordination of laboratory maintenance. This role is not lab-focused; it prioritizes change controls, deviations, CAPAs, action ownership, testing specifications and SOP updates, timely release monitoring, QC metrics, and cross-functional project support. The Specialist authors and updates specifications, SOPs, and other GMP-related documents; owns or leads change controls, deviation investigations, CAPAs, impact assessments, and projects; and follows up with relevant teams to meet target dates. The position also supports audits, training, process improvements, and compliance activities, working under limited supervision and in accordance with standard operating and QC procedures.

Requirements

Bachelor’s degree in a science- or engineering-related field from an accredited institution and four years of work experience in analytical testing in a GMP-regulated industry or equivalent; alternatively, a master’s degree in a science- or engineering-related field from an accredited institution and two years of such experience.
Proven experience with technical review, analysis, and interpretation of scientific data.
Experience with computer-based systems; experience with process control systems is described as ideal.
Previous experience authoring SOPs, methods, and/or work instructions.
Experience interacting with auditors and regulators, understanding the subject matter, and communicating concisely within areas of expertise.
Experience troubleshooting technical problems and/or equipment.
Expertise performing analytical methodologies across scientific principles relevant to biopharmaceutical manufacturing.
Expert understanding of analytical methods and validation principles in pharmaceutical, biopharmaceutical, or medical-device industries.
Ability to make critical decisions, work independently with very little supervision, champion problem resolution, recognize when to escalate, and provide compliant solutions to complex validation issues.
Ability to concentrate on detail-oriented work in a complex technical environment with a Quality and right-first-time mindset.
Track record of troubleshooting and applying the scientific method to solve technical problems.
Skills in Quality Systems, including CAPA, change control, deviations, and OOX.
Ability to work effectively as part of a high-performing team and collaborate with staff.
Demonstrated ability to lead projects of low complexity.

Nice To Haves

Experience in a quality and cGMP environment.
Knowledge of deviations, change control, and CAPAs.
Pharmacopeial knowledge, such as USP and Ph. Eur., and knowledge of ICH.
Problem-solving capabilities, including analytical thinking and recognizing data trends.
Detail orientation and a right-first-time mindset.
Communication and collaboration skills.
Experience working with cross-functional teams.
Openness to change and an interest in driving improvements and efficiencies.

Responsibilities

Provide technical oversight, coordinate, and review QC analytical testing of bulk drug substance and drug product in a multi-product facility.
Serve as a subject matter expert in 3–5 analytical methodologies across different scientific principles.
Lead routine or platform method transfers, validations, qualifications, verifications, and technical assessments.
Perform technical review, interpretation, trending, quality review, and investigation of atypical results.
Coordinate routine maintenance activities and represent the group in simple or routine equipment qualifications.
Identify and implement improvements to laboratory processes and compliance activities.
Prepare and manage new or non-routine quality and compliance documents and activities, including test methods, specifications, plans, reports, forms, and SOPs.
Execute and oversee QC compliance deliverables, including deviations, investigations, OOS issues, CAPAs, change controls, and impact assessments.
Represent QC as a subject matter expert during audits for assigned topics.
Document work in accordance with cGMP and cGDP, follow site regulations and procedures, promptly report abnormalities and deviations, and adhere to safety standards.
Maintain laboratory areas according to predefined 5S standards.
Manage projects involving core or platform processes within Quality, including process-improvement and CAPA projects.
Maintain required training and train technicians and associates; conduct complex-topic and scientific-principle training, establish curricula, and implement training improvements.
Lead OOX and OOE investigations, identify protocol discrepancies, establish appropriate root causes, assess product-quality impact, and ensure deviations are closed promptly.
Influence and lead cross-functional meetings to resolve issues and develop solutions.
Own or lead change controls, deviations, CAPAs, action items, and impact assessments; follow up with appropriate areas to meet target dates.
Update testing specifications and SOPs, monitor timely release (including incoming materials) and QC metrics, and represent QC DRD in cross-functional projects.