Sr. QC Validation Scientist

job summary:
Step into a key technical role driving site-wide validation across AQC and QC Microbiology. You will design validation blueprints, approve method transfers, untangle lab discrepancies, and oversee SCADA/MES systems to safely deliver biopharmaceuticals to patients.

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

responsibilities:

• Lead end-to-end method validation, qualification, and transfers across AQC and QCM.
• Author and approve life cycle validation protocols, technical transfer packages, and raw material strategies.
• Act as SME for complex method troubleshooting, discrepancy resolution, and OOS/OOT root-cause investigations.
• Oversee validation strategy for automated/computerized systems (SCADA, MES, Kneat) adhering to cGMP and 21 CFR Part 11.
• Lead IOQ/PQ protocols for facilities, utilities, instrumentation, and equipment.
• Use statistical analysis to set validation criteria and resolve technical challenges.
• Align cross-functional deliverables across QC, IT, and Engineering, mentoring junior staff.

 
qualifications:
Required:

• Bachelor's Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or a related scientific discipline.
• Minimum of 7+ years of progressive analytical development and method validation experience in a cGMP pharmaceutical or biopharmaceutical manufacturing environment.
• Proven track record authoring, reviewing, and approving complex Life Cycle Validation documents using paperless validation software.
• Deep technical experience leading Commissioning, IOQ, and PQ protocols for lab facilities, utilities, instrumentation, and computer systems (including SCADA and MES).
• Strong background in both Analytical Quality Control (AQC) and QC Microbiology (QCM) laboratory instrument qualification and method transfer execution.
• Advanced statistical knowledge and data analysis capabilities for troubleshooting method variability and setting scientific acceptance criteria.
• Expert-level understanding of cGMP, QSR, USP, ICH guidelines, and 21 CFR Part 11 regulatory requirements.

Preferred:

• Master's or Ph.D. in Chemistry, Biochemistry, Microbiology, or a related scientific field.Specialized
• Direct proficiency with the Kneat paperless validation program.
• Experience leading investigation root-cause teams for method discrepancies/OOS and mentoring junior validation scientists.

#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 us.fitly.work.




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.