Senior QC Associate, Potency

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action; we believe that good business means a better world.Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.Job Summary:The Quality Control Specialist (Lead) within the Operations group of the Quality Control Organization supports all bioassay activities required of HTO QC, focusing on testing and execution of assignments as assigned by site operations, QC specialists, and/or QC management. The QC Specialist plays a meaningful role in maintaining and improving functional operations within QC, enabling the organization to support all manufacturing and business testing needs. This role’s focus is to serve as the QC department’s subject matter expert in Quality Control Bioassay Operations processes and provide guidance, mentorship, and training to junior analysts. This role works with QC leadership and cross-functional partners on QC-related projects and continuous improvement initiatives. The Opportunity:Coordinate scheduling, logistics, and day-to-day testing activities of analysts and provide overall technical and logistical guidance within their QC focus group/testing pod.Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures. Routine performing, and reviewing a variety of  Bioassays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment. Interprets data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. Supports method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes.Ensure maintenance and calibration of laboratory equipment and systems. Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures is also required.     Core Technical SkillsGMP QC: Significant experience in executing cell culture and bioassays in a GMP regulated QC laboratory according to standard operating procedures.Assay Execution & Troubleshooting: Demonstrated expertise in developing, troubleshooting, and executing mechanism-of-action  reflective biological assays. This includes:Cell-based assays (reporter gene, cell proliferation, cytotoxicity, apoptosis, ADCC/CDC).Immunoassays and binding methodologies Various mammalian cell culture techniques (suspension and adherent cell lines, generation of cell banks).Analytical Method Lifecycle: Proven experience in method validation, method transfer (internal and external/CMO), and routine lifecycle management of potency assays for commercial release and stability testing.Data Analysis & Statistics: Proficiency in statistical evaluation of bioassays, including parallel line analysis, 4-PL/5-PL curve fitting, and assessing assay capabilities.Systems & Software: Advanced proficiency with industry-standard software and systems, including SoftMax Pro, JMP (or similar statistical software), LIMS (Laboratory Information Management Systems), ELN (Electronic Laboratory Notebooks), and QMS platforms (e.g., TrackWise, Veeva Vault).       Who You Are: Bachelor’s Degree with 5-7 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry. 3-5 years experience with a Master’s Degree or 0-2 years experience with PhD/JD.cGMP Expertise: Minimum of 2 years working directly within a highly regulated commercial Quality Control (QC) or cGMP environment.Investigations & Problem Solving: Extensive experience leading and authoring complex laboratory investigations, including Out of Specification (OOS), Out of Trend (OOT), Deviations, and CAPAs using root cause analysis methodologies.Technical Writing: Exceptional ability to author, review, and approve standard operating procedures (SOPs), analytical test methods, validation protocols, and summary reports.Data Integrity: Strict adherence to ALCOA+ principles and an uncompromising commitment to data integrity and compliance in a commercial setting.Significant potency (bioassay) experienceSound knowledge of GMP and considerable analytical/QC experienceExperience developing and validating analytical methodsProfessional level written and oral communication skills, ability to organize and present information informal and formal group settingDemonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical method development, qualification/validation, and implementationStrong analytical intuition, troubleshooting skills (e.g., analytical instrumentation), and problem-solving capabilitiesWork in an office and laboratory environmentFlexibility in problem solving, providing direction and work hours to meet business objectivesDemonstrated ability to work independently to accomplish tasksAbility to sit, stand and move within work space for extended periods and lift up to 25 lbsMay be required to sit at a computer terminal or laboratory bench for extended periodsAbility to