Genentech · 5 days ago
QC Senior/Principal Specialist - Contract Laboratory Organization Oversite
Hillsboro, OR
Full-time, Contract
Onsite
Senior Level, Lead/Staff
$90K/yr - $167K/yr
6+ years expGenentech, a member of the Roche group, is dedicated to groundbreaking science in healthcare. The QC Senior/Principal Specialist will oversee Quality Control activities related to contract laboratory organizations, ensuring compliance with cGMP regulations and supporting method validation and audits.
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
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
Clear Customer Focus and ability to anticipate future stakeholder needs
Team player contributing to an environment of strong team spirit, high motivation and delivery with a sense of urgency
Excellent verbal and written communication skills enabling synthesis of data, processes and information
Ability to summarize complex matters in simple terms and have a good understanding of a complex organization
Embodiment of PT lean principles and methods while fostering a mindset of quality, innovation and continuous improvement
Ability to nurture an environment where people feel included, safe to learn through experimentation, and able to do their best work
Demonstrated business acumen and experience foundational to a solution-oriented attitude
Ability to stay focused in ambiguous and pressured situations
Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP
Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization
Interpreting data, troubleshooting assay failures and equipment issues while adhering to strict guidelines on cGMP documentation
Supporting method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations
Ensuring maintenance and calibration of laboratory equipment and systems
Supporting during cGMP audits and Health Authority inspections as needed
Leading, forecasting and coordinating activities between HTO QC and CLOs
Executing and reviewing contracts, audits, methods, transfers and data
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