Genentech · 18 hours ago
QC Senior/Principal Specialist - CLO Oversite
Hillsboro, OR
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $167K/yr
6+ years expGenentech, a member of the Roche group, is dedicated to pursuing groundbreaking science to discover and develop medicines for serious diseases. In this role, you will be the primary contact for QC related CLO activities, implementing Quality Control policies and troubleshooting issues while adhering to cGMP guidelines.
BiotechnologyLife ScienceManufacturing
Responsibilities
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 sampling, performing, and reviewing a variety of assays 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
Leading, forecasting and coordinating activities between HTO QC and CLOs. Including executing and reviewing contracts, audits, methods, transfers and data. You will be a subject matter expert on these methods and activities
Qualification
Required
Bachelor's of Science degree with 8-11 years of dynamic experience in the pharmaceutical or scientific industry or 6-8 years of experience with a graduate degree
3 years of experience working in a cGMP or similarly regulated environment is required
Bachelor's of Science degree with 15+ years of experience in the pharmaceutical industry or 13+ years with a Graduate degree
3+ years of experience working in a cGMP or similarly regulated environment
Excellent verbal and written communication skills which enable you to synthesize data, processes and information - summarizing complex matters in simple terms
Ability to anticipate future stakeholder needs
Ability to contribute to an environment of strong team spirit, high motivation and delivery with a sense of urgency
Demonstrated business acumen and experience which is foundational to your solution-oriented attitude
Ability to stay focused in ambiguous and pressured situations
Ability to nurture an environment where people feel included, feel safe to learn through experimentation, feel able to be themselves and have the opportunity to do their best work
Benefits
Relocation benefits are provided
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
Recent News
2026-01-23
Genetic Engineering News
2026-01-23
Company data provided by crunchbase