Specialist, QC Lab General, Onsite, Fremont CA

Boehringer Ingelheim•Fremont, CA

2d•$88,000 - $132,000•Onsite

About The Position

The Specialist, QC Lab General works in a Quality Control functional or technical area, such as HPLC/CE, potency testing, residual impurities, physicochemical/drug product, or raw materials and cleaning validation/verification. The role provides technical oversight and coordinates and reviews analytical testing of bulk drug substance and drug product in a multi-product facility. The Specialist serves as a subject matter expert in three to five analytical methodologies and leads routine or platform method transfers, validations, qualifications, verifications, and technical assessments. This position is not lab-focused; it prioritizes quality-system ownership and cross-functional coordination, including change controls, deviations, CAPAs, specifications, SOPs, QC metrics, and timely release monitoring. The Specialist authors and updates GMP-related documents, follows up with stakeholders to meet target dates, and owns or leads projects such as process improvements and CAPAs. The role also performs technical review and interpretation of data, trends and investigates atypical results, and supports audit readiness and compliance activities. The Specialist works under limited supervision and follows standard operating and QC procedures, cGMP, cGDP, site regulations, and safety standards. Responsibilities include leading investigations, training colleagues, maintaining training compliance, coordinating routine maintenance and equipment qualifications, and working with cross-functional teams to resolve quality and technical issues.

Requirements

Bachelor's degree from an accredited institution in a science- or engineering-related field 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 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 desirable.
Previous experience authoring SOPs, methods, and/or work instructions.
Experience interacting with auditors and regulators and communicating subject-matter expertise clearly and concisely.
Experience troubleshooting technical problems and/or equipment.
Subject-matter expertise performing analytical methodologies involving different scientific principles relevant to biopharmaceutical manufacturing.
Expertise in analytical methods and the ability to make critical decisions, work independently with very little supervision, champion problem resolution, know when to escalate, and provide compliant solutions for complex validation issues.
Expert understanding of analytical methods and validation principles in pharmaceutical, biopharmaceutical, or medical-device industries.
Ability to perform detail-oriented work in a complex technical environment 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, 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, with knowledge of deviations, change control, and CAPAs.
Pharmacopeial knowledge, such as USP or Ph. Eur., and knowledge of ICH.
Problem-solving capabilities, including analytical thinking and recognizing data trends.
Detail-oriented approach with a right-first-time mindset.
Strong communication and collaboration skills, including working with cross-functional teams.
Openness to change and ability to drive 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 three to five analytical methodologies and represent QC during audits on relevant topics.
Lead routine or platform method transfers, validations, qualifications, verifications, and technical assessments.
Identify and implement improvements to laboratory processes and compliance activities.
Prepare and maintain new or non-routine test methods, specifications, plans, reports, forms, SOPs, and other GMP-related documents.
Own or lead change controls, deviations, CAPAs, impact assessments, action items, and related quality-system deliverables.
Monitor timely release, including incoming materials, and track QC metrics; follow up with relevant areas to meet target dates.
Lead OOX and OOE investigations, assess protocol discrepancies, determine root causes, assess product-quality impact, and ensure deviations are closed promptly.
Review, interpret, trend, and investigate atypical results.
Document work according to cGMP and cGDP; comply with site regulations and report abnormalities and deviations promptly and accurately.
Adhere to safety standards, identify unsafe situations or habits, and escalate them appropriately.
Establish laboratory areas according to predefined 5S standards and represent the group in simple or routine equipment qualifications.
Coordinate routine maintenance activities and manage projects involving core or platform processes within Quality.
Maintain personal training compliance and train technicians and associates after trainer qualification; conduct group training on complex topics and scientific principles.
Establish training curricula, train others as a subject matter expert, implement new training procedures, and drive continuous improvement.
Influence and lead interdepartmental meetings with cross-functional team members to resolve issues and develop solutions.
Serve as a QC DRD representative for cross-functional projects.