New · posted Nov 11
Genentech · Biotechnology
Quality Control Associate I
- South San Francisco, CA
- On-site
- Full-time
- Associate & Specialist
The role
- You perform biochemical and immunological cell-based and non-cell-based assays to support clinical and commercial products.
- You support critical operations including process development, product characterization, stability studies, in-process testing, and lot release testing within a cGMP environment.
- You review and release assay data across both electronic and paper-based formats while maintaining high compliance standards.
- You prepare laboratory reagents, monitor assay performance, and clearly present quality results to cross-functional teams.
- You uphold data integrity and quality standards by applying Good Documentation Practices (GDP) and ALCOA++ principles.
- You maintain high laboratory standards by actively participating in Environmental Health and Safety (EHS) practices, 5S workplace organization, and routine equipment upkeep.
- You leverage quality systems and laboratory informatics, including LIMS, electronic lab notebooks (ELN), and document management platforms.
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
As a Quality Control Associate I in our Bioassay US Testing Group, you will play an essential role in advancing clinical and commercial therapeutics. Our team is committed to high-quality science and collaboration, delivering critical testing that directly impacts patient lives. This role offers an engaging, hands-on laboratory environment with continuous opportunities to develop your technical and analytical expertise in biopharmaceuticals.
What you need
- You hold a Bachelor’s degree in Biological Sciences or a related field with 1–2 years of relevant experience in a Quality Control or GxP laboratory environment.
- You bring proven, hands-on laboratory experience performing cell-based and non-cell-based assays.
- You possess strong working knowledge of cGMP standards and hands-on experience with aseptic cell culture techniques.
- You are proactive, detail-oriented, and able to work both independently and collaboratively across multidisciplinary teams.
- You demonstrate clear written and verbal communication skills well-suited for a fast-paced, quality-focused setting.
Preferrednice to have
- You have hands-on experience working with industry-standard GxP electronic systems, such as SoftMax Pro, LIMS, and Veeva QMS.
Relocation benefits are not available for this posting.
This position also qualifies for the benefits detailed at the link provided below.
Benefits
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Pay and benefits
$60,600 – $112,500 a year
Employer providedThe expected salary range for this position based on the primary location of California is $60,600 - $112,500 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Discretionary annual bonus
Where you'll work
South San Francisco, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAEqual opportunity, accessibility and legal noticesGenentech's statements, word for word
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in California16 roles publishing pay
Associate & Specialist roles in the US90 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $60,600 | — | $112,500 |
| California (middle half) | $63,625 | $64,000 | $79,000 |
| All US (middle half) | $64,000 | $73,500 | $88,250 |
This role: Genentech's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 265 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Genentech's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods9
- GMP and compliance5
- Collaboration and leadership4
- Data and digital systems3
- Documentation and SOPs2
- Quality systems and risk2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human useNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
Company hiring pulse
Genentech on Regulatory Jobs
- 25
- Open roles
- 25
- Distinct roles
- 5
- Locations
By discipline
- Quality14 54%
- Regulatory8 31%
- Clinical4 15%
By level
- Senior & Principal17 65%
- Director4 15%
- VP & Executive2 8%
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Quality Control Associate I at Genentech
Applications close November 16. $61K–$113K a year, employer provided.