Aseptic & Sterility Assurance Specialist

job summary:
Ready to bring your microbiology expertise to a industry-leading biopharmaceutical leader? We are seeking a Sterility Assurance Specialist in Berkeley, CA to lead technical oversight for environmental monitoring, microbial risk assessments, and contamination control programs. This high-impact individual contributor role offers a fantastic opportunity to drive contamination control strategies for cutting-edge biomanufacturing.

location: Berkeley, California
job type: Contract
salary: $48.45 - 56.45 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Lead technical assessments for microbial contamination events, environmental monitoring excursions, and recurring organism patterns.
• Perform microbiological risk assessments covering aseptic processing, cleanroom operations, cleaning/disinfection, and facility utilities.
• Review microbial identification results to determine source plausibility and evaluate cross-area contamination signals.
• Investigate Grade A-D contamination events, partnering with QC teams to identify root causes and adverse trends.
• Support Media Fill/Aseptic Process Simulation (APS) assessments, intervention representativeness, and CAPA effectiveness.
• Develop risk-based escalation criteria, site decision trees, and technical guidance for contamination control.

 
qualifications:
Required:

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or related field.
• Minimum 5 years of relevant experience in QC Microbiology, environmental monitoring, aseptic processing, or sterility assurance.
• Strong expertise in environmental monitoring, bioburden, cleanroom controls, and root-cause contamination investigations.
• Demonstrated experience supporting GMP deviations, CAPAs, risk assessments, and technical documentation.

Preferred:

• Experience with Grade A/B aseptic processing, biologics, cell therapy, or sterile drug product manufacturing.
• Familiarity with EU GMP Annex 1, FDA aseptic guidance, and USP microbiology chapters.

#LI-PV1

skills: Biology, Microbiology, QC Review, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Assurance (QA), Quality Control (QC)


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.