QC Analyst II

job summary:
Take ownership of critical cGMP testing and method implementation in a high-impact Quality Control setting. As a Senior Quality Compliance Specialist in Thousand Oaks, you will drive analytical method transfers, run complex biological/chemical analyses, and keep our lab compliant and audit-ready from day one.

location: Newbury Park, California
job type: Contract
salary: $39 - 65 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Perform biological, chemical, and physical testing on raw materials, in-process samples, and final products per SOPs.
• Drive the implementation of new testing methodologies and sample types into QC lab operations.
• Investigate nonconformances, troubleshoot unexpected results, and draft/update QC SOPs.
• Review test data for CGDP compliance and execute sample release actions in LIMS.
• Support validation protocol deliverables and perform routine lab equipment maintenance/calibrations.

 
qualifications:
Required:

• High School degree or equivalent and a minimum 2 years of related work experience
• Prior experience with laboratory functions, test methods, equipment including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures).
• Prior experience with laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• Experience with wet and instrumental methods of analyses as well as operating and troubleshooting procedures for lab equipment.

Preferred:

• Bachelor's Degree in Chemistry, Microbiology or Biological Sciences.
• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment.
• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
• Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs.
• Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis.

#LI-KH1

skills: Good Manufacturing Practices (GMP), Deviation Investigation, Process Validation, Quality Control (QC), Food and Drug Administration (FDA), International Council for Harmonization (ICH)


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 View email address on 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.