SR Specialist OR Specialist, QC Lab General, Fremont CA

Job Summary Employee assigned to QC functional or technical area in HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Raw Materials/Cleaning validation/verification. Performs duties under limited supervision and according to standard operating and QC procedures. Technical and Quality lead for non‑routine, new method transfer/validations/qualifications, verifications and technical assessments. Responsible for quality and compliance activities including new test methods, specifications, plans, reports, forms, SOPs, etc. as a new hire in the department. Group representative on equipment qualifications for new and novel technology. Duties & 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 the quality risk assessment, onboarding, qualification and implementation of non‑routine, new 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, specs, plans, reports, forms, SOPs, etc. with no previous experience within the department. Cross‑functional project team lead responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls) with impact across multiple functional areas. 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. Represents team on global team initiatives and external facing client teams; project leader of non‑routine, new initiatives with local cross‑functional impact; establishes timelines, sets goals and implements strategy for site‑wide QC projects. 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 trains others as an SME; implements new training procedures and drives continuous improvement; improves cross‑training and coaches others. Leads OOS 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; influences and leads inter‑departmental meetings with cross‑functional managers to resolve issues and produce solutions. Manages deviation investigations as applicable and provides product quality impact assessment. Leads complex deviation investigations as applicable and provides product quality impact assessment. Responsible for training others. Requirements Bachelor's Degree in a science or engineering related field from an accredited institution, with six (6) years of experience in analytical testing in a GMP regulated industry or equivalent. Master's Degree in a science or engineering related field from an accredited institution, with four (4) years of experience in analytical testing in a GMP regulated industry or equivalent. Ph.D. in a science or engineering related field from an accredited institution, with two (2) years of experience in analytical testing in a GMP regulated industry or equivalent. Ph.D. preferred. 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 providing oral and poster presentations on complex technical problems to other scientific experts. Subject matter expert in performing analytical methodologies within different scientific principles relevant to biopharmaceutical manufacturing. Expert in analytical methods, executes critical decision‑making, works independently with very little supervision, champions problem resolution, knows when to escalates 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, OOS, etc.). Ability to work as part of a high‑performing team and collaborate effectively with staff. Ability to interact with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise. Proven capability to independently solve complex technical problems. Demonstrated ability to lead cross‑functional projects of moderate complexity. Proven track record to mentor, train and lead others within discipline. Desired Skills, Experience and Abilities This role is responsible for ensuring the quality, compliance, and data integrity of QC records while maintaining inspection readiness and supporting continuous improvement initiatives across the organization. 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 is preferred. Knowledge of microbiology, aseptic manufacturing, environmental monitoring, and contamination control strategies is highly desirable. Ensure compliance and quality oversight of QC records, data integrity controls and documentation practices. Support audit and inspection readiness activities, including preparation, management of responses, and follow‑up actions. Author and review trend reports, compliance metrics, and quality assessments. Salary Base salary typically between $75,000 and $122,000, with additional variable or performance‑based bonuses and other compensation components available based on business need and candidate experience. #J-18808-Ljbffr Boehringer Ingelheim