Quality Control Analyst - Product Analytical Testing

Reposted 3 Days Ago
Be an Early Applicant
Hillsboro, OR, USA
In-Office
65K-99K Annually
Senior level
Healthtech • Biotech
The Role
Perform and review in-process, finished product, raw material, incoming inspection, and environmental monitoring assays in a cGMP lab. Troubleshoot assay and equipment issues, support method validation/transfers, maintain/calibrate lab equipment, and assist with audits and OOS investigations to ensure compliance with quality standards.
Summary Generated by Built In

At Roche, we advance science so that we all have more time with the people we love. Become a Genentech/Roche member of a collaborative team that creates outcomes that matter for patients, customers and the company.

The Opportunity:

The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)

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.

Who you are:

(Minimum Requirements)
  • BS/BA degree, or minimum of 5 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry.

Work Environment/Physical Demands/Safety Considerations:

  • Work in an office and laboratory environment

  • Lift up to 25 lbs may be required.

  • Ability to sit, stand, and move within work space for extended periods

  • May be required to sit at a computer terminal for extended periods.

  • Working location is Onsite.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Oregon is $64,800.00 - $98,500.00 Annually. 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.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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.

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.

Skills Required

  • BS/BA degree
  • 5+ years experience in a cGMP or similarly regulated environment in the pharmaceutical or science industry
  • Experience performing routine sampling and running a variety of assays for in-process, drug product, finished product, raw materials, incoming inspection, and environmental monitoring
  • Experience interpreting data, troubleshooting assay failures and equipment issues with cGMP documentation
  • Experience supporting method validation, method transfers, performance qualifications, and OOS investigations
  • Experience ensuring maintenance and calibration of laboratory equipment and systems
  • Experience supporting cGMP audits and health authority inspections
  • Ability to work onsite in an office and laboratory environment (ability to sit, stand, move for extended periods)
  • Ability to lift up to 25 lbs

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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