Quality Control Analyst I
Roche
Summary
As a Quality Control Analyst 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.
Job description
The Opportunity
- Perform biochemical and immunological cell-based and non-cell-based assays to support clinical and commercial products.
- Support critical operations including process development, product characterization, stability studies, in-process testing, and lot release testing within a cGMP environment.
- Review and release assay data across both electronic and paper-based formats while maintaining high compliance standards.
- Prepare laboratory reagents, monitor assay performance, and clearly present quality results to cross-functional teams.
- Uphold data integrity and quality standards by applying Good Documentation Practices (GDP) and ALCOA++ principles.
- Maintain high laboratory standards by actively participating in Environmental Health and Safety (EHS) practices, 5S workplace organization, and routine equipment upkeep.
- Leverage quality systems and laboratory informatics, including LIMS, electronic lab notebooks (ELN), and document management platforms.
Who you are
- 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.
- Bring proven, hands-on laboratory experience performing cell-based and non-cell-based assays.
- Possess strong working knowledge of cGMP standards and hands-on experience with aseptic cell culture techniques.
- Be proactive, detail-oriented, and able to work both independently and collaboratively across multidisciplinary teams.
- Demonstrate clear written and verbal communication skills well-suited for a fast-paced, quality-focused setting.
Preferred
- Hands-on experience working with industry-standard GxP electronic systems, such as SoftMax Pro, LIMS, and Veeva QMS.
Requirements
- Bachelor's degree in Biological Sciences or a related field
- 1–2 years of relevant experience in a Quality Control or GxP laboratory environment
- Hands-on laboratory experience performing cell-based and non-cell-based assays
- Strong working knowledge of cGMP standards
- Hands-on experience with aseptic cell culture techniques
- Proactive, detail-oriented, able to work independently and collaboratively
- Clear written and verbal communication skills
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement benefits
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.