The Senior Analyst, Quality Control Analytical is responsible for the rigorous execution of lot release, stability, and non-routine testing of pharmaceutical drug substances and products under strict cGMP guidelines. This role requires an experienced scientist capable of operating with minimal supervision to ensure the timely delivery of high-quality data that directly impacts patient safety. The successful candidate will transition seamlessly between routine analytical execution and acting as a technical lead for laboratory investigations and regulatory inspections.
location: Novato, California
job type: Contract
salary: $36.34 - 42.75 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
- Execute complex biochemical, physical, and chemical analyses of test samples under cGXP to meet critical manufacturing and clinical timelines.
- Maintain technical mastery over a broad portfolio of advanced separation science assays, including HPLC, UPLC, and Capillary Electrophoresis (CE).
- Perform sophisticated data evaluation against defined specifications, identifying trends or deviations that require immediate technical investigation.
- Drive continuous improvement by assisting in the revision of standard operating procedures (SOPs), method validations, and cross-site method transfers.
- Serve as a technical Subject Matter Expert (SME) and mentor, providing educational development for junior analysts and representing the laboratory during internal and external regulatory audits.
- Lead laboratory investigations and troubleshooting efforts, applying deep technical understanding to resolve complex analytical challenges in non-routine situations.
- Cultivate a culture of uncompromising quality and safety, holding all laboratory personnel accountable to established compliance standards.
qualifications:
Required:
- Bachelor's Degree (B.S./B.A.) in Chemistry, Biology, Biochemistry, or a related scientific discipline.
- Minimum of 3 years of experience operating within a cGMP or GLP laboratory environment.
- At least 2 years of hands-on experience in separation sciences, specifically utilizing HPLC, UPLC, or CE platforms.
- Demonstrated leadership aptitude and the ability to work independently with minimal oversight.
- Advanced proficiency in data management systems and Microsoft Office Suite (Excel, Word).
- Exceptional technical writing and verbal communication skills, with a proven track record of meticulous documentation.
- 3 to 5 years of professional experience specifically within a Quality Control (QC) laboratory setting.
- Advanced expertise (3+ years) in high-resolution separation techniques and associated instrumentation (e.g., Waters, Dionex, Sciex, ProteinSimple).
- Direct experience participating in or supporting regulatory inspections.
skills: Biology, Chemistry, GMP (Good Manufacturing Practice), Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Good Laboratory Practices (GLP), Capillary Electrophoresis (CE), Quality Control (QC), Quality Control Testing
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
