Quality Control Specialist - Analytical Chemistry

Quality Control Specialist - Analytical Chemistry

Job Summary:

Join our team as an experienced QC Specialist and take the lead in implementing and validating crucial new analytical methods. Utilize deep expertise in advanced chromatography (HPLC, UPLC, etc.) and other chemistry instrumentation, focusing on complex assay troubleshooting while maintaining strict GMP/GDP compliance.

Location:

Berkeley, California
Job Type: Contract
Salary: $30.49 - 35.87 per hour

Work Hours:

9 AM – 5 PM

Education:

Bachelor’s Degree

• Supports implementation of new methods in the QC Chemistry department.
• Maintains appropriate logs, notebooks, and other records, including electronic documents.
• Performs method feasibility studies, method development, and laboratory assays for method validation protocols using various chemistry instrumentation (HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter).
• Applies thorough knowledge of chromatography (SEC, ION, NORMAL, REVERSE, ION‑PAIR, etc.), electrophoresis (PAGE and/or agarose), simple chemistry methods (e.g., spectrophotometry), and wet chemistry for sample preparation. Knowledge of biologics and manufacturing processes is required.
• Troubleshoots assays and analytical instrumentation needed for method performance, including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, and Polarimeter.

• Bachelor’s Degree (B.S.) in Chemistry, Biochemistry, or a closely related discipline.
• 3+ years of experience in the pharmaceutical or biopharmaceutical industry, with significant tenure in a QC laboratory environment. (A Master’s degree and 2 years, or a Ph.D. with no experience, are also acceptable).
• Hands‑on proficiency with major chromatographic software, specifically EMPOWER, LIMS, and SAP systems.
• Experience generating method development reports and method validation reports.
• Expert-level knowledge of and strict adherence to SOPs, pharmacopoeial requirements, GDP, and GMP regulations.
• Proven ability to troubleshoot complex analytical instrumentation and optimize existing laboratory assays.
• Capable of managing multiple tasks, working effectively with multiple technical leads, and interfacing with other functions such as manufacturing and research personnel.

• Over 3 years of experience directly focused on analytical method development and formal validation within a cGMP setting.

• Laboratory Information Management Systems (LIMS)
• Ultra Performance Liquid Chromatography (UPLC)
• High Pressure Liquid Chromatography (HPLC)
• UV‑Vis Spectroscopy
• Good Manufacturing Practices (GMP)
• Quality Control (QC)
• Good Documentation Practices (GDP)

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, please contact

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. Randstad offers a comprehensive benefits package, including medical, prescription, dental, vision, AD&D, life insurance, short‑term disability, and a 401(k) plan (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 and the California Fair Chance Act. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws.