Join our team as an experienced Quality Control (QC) Specialist and take the lead in implementing and validating crucial new analytical methods. You will utilize your deep expertise in advanced chromatography (HPLC, UPLC, etc.) and other chemistry instrumentation, focusing on complex assay troubleshooting and maintaining strict GMP/GDP compliance.
location: Berkeley, California
job type: Contract
salary: $30.49 - 35.87 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Supports implementation of new methods in Quality Control (QC) Chemistry department.
- Maintains appropriate logs, notebooks and other records including electronic documents.
- Performs method feasibility studies, method development, and performs laboratory assays for method validation protocol execution utilizing various chemistry instrumentations (HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter).
- 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 to prepare samples. Knowledge of biologics and manufacturing processes.
- Troubleshoots assays and analytical instrumentation needed for method performance including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter.
qualifications:
Required:
- Bachelor's Degree (B.S.) in Chemistry, Biochemistry, or a closely related technical/scientific discipline.
- Three (3)+ years of experience in the pharmaceutical or related biopharmaceutical industry, with a significant tenure in a Quality Control (QC) laboratory environment. (A Master's degree and 2 years, or a Ph.D. with no experience, is also acceptable).
- Demonstrated 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 more than one technical leads, 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.
skills: 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 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.
