Quality Control Validations Specialist

job summary:
Are you ready to elevate your career in Quality Control with a top-tier biopharmaceutical leader? We are seeking a detail-oriented QC Analytical Scientist to drive method validation and analytical transfer in a fast-paced cGMP environment. If you thrive on solving complex technical challenges and maintaining laboratory excellence, this is the dynamic opportunity for you.

location: Newbury Park, California
job type: Contract
salary: $50 - 62 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Drive analytical method validation and transfer for laboratory methodologies, including raw materials qualification.
• Support test plan execution, discrepancy resolution, and completion approvals.
• Maintain laboratory equipment in a validated state and support installation, operational qualification (IOQ), and troubleshooting.
• Generate protocols, technical reports, and regulatory documentation using sound statistical techniques.
• Ensure all analytical methods meet internal standards, cGMP, and regulatory requirements (21CFR, USP, ICH).

 
qualifications:

• Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.
• Minimum 1 year of analytical development/validation experience in a pharmaceutical or biopharmaceutical manufacturing environment (or an advanced degree).
• Strong working knowledge of cGMP, lab unexpected results investigations, and regulatory standards (21CFR, USP, ICH).
• Demonstrated technical writing skills and ability to perform statistical data analysis.

#LI-AM1

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.