Drive contamination control strategy as a Sterility Assurance Principal Specialist for a Top-Tier Global Pharma Leader in Berkeley, CA. This premier contract role serves as a key individual contributor translating site contamination control strategies into actionable program deliverables, risk management frameworks, and inspection-readiness initiatives across cross-functional life sciences teams.
location: Berkeley, California
job type: Contract
salary: $55.00 - 61.32 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Support continued implementation of the Berkeley Site Sterility Assurance and Contamination Control Program, including program roadmap, workstream tracking, governance materials, and execution follow-up.
- Maintain the site CCS / sterility assurance action tracker, including assigned owners, due dates, dependencies, risk ranking, progress updates, and escalation needs.
- Support preparation of Sterility Assurance Council materials, including agendas, action logs, decision records, risk summaries, and leadership updates.
- Partner with the QRM program/SME to ensure contamination control risks are documented, prioritized, escalated, and reviewed using approved site risk-management processes.
- Support development of site-level sterility assurance metrics by integrating existing source data from QA, QC Microbiology, Engineering, Manufacturing, Validation, and Operations without duplicating functional dashboards.
- Prepare periodic Sterility Assurance / Contamination Control health summaries highlighting key risk signals, open high-risk gaps, overdue actions, repeat contamination patterns, CAPA effectiveness, and inspection-readiness status.
- Assist with inspection-readiness activities related to CCS, contamination control governance, QRM linkage, risk-based decisions, CAPA tracking, and sterility assurance program maturity.
- Support development and revision of program-level tools such as charters, templates, decision trees, governance triggers, risk review forms, dashboards, and communication materials.
- Coordinate assigned deliverables across cross-functional stakeholders while maintaining clear documentation, follow-up, and escalation of risks or overdue items.
- Support execution of the site Sterility Assurance and Contamination Control Program, roadmaps, and governance frameworks.
- Maintain the site action tracker, prioritizing risk rankings, assigned owners, dependencies, and escalation pathways.
- Prepare Sterility Assurance Council materials including decision records, action logs, agendas, and executive summaries.
- Interface with QRM to ensure contamination control risks are formally documented, reviewed, and mitigated under GMP processes.
- Compile quarterly Sterility Assurance health dashboards by integrating source data across QA, QC Micro, Engineering, and Manufacturing.
- Lead inspection-readiness activities regarding contamination control maturity, CAPA effectiveness, and regulatory alignment.
qualifications:
Required:
- Bachelor's degree in Microbiology, Biotechnology, Engineering, Pharmaceutical Sciences, or related scientific discipline.
- 8+ years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, or aseptic processing environments.
- Strong knowledge of GMP quality systems, CAPA, change control, risk management, and inspection readiness.
- Proven ability to coordinate cross-functional programs, action trackers, and dashboards across QA, QC, and MSAT teams.
- Direct experience with Contamination Control Strategy (CCS) implementation, EU GMP Annex 1, and FDA aseptic processing guidance.
- Background in aseptic manufacturing, environmental monitoring, microbial investigations, or FMEA risk tools.
skills: Biology, Microbiology, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), 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 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.
