Job Details

Sterility Assurance Specialist (Contract)Type: Contract — up to $56/hrDuration: 12–18 months, with extension or conversion possibleAbout the RoleOur client, a global life sciences manufacturer, is seeking a Sterility Assurance Specialist to support its site sterility assurance and contamination control program. This is an individual contributor role — no direct reports — reporting to the site's Contamination Control / Sterility Assurance Lead.You will be the person who reads the microbial data and says what it means. Environmental and personnel monitoring excursions, recurring organisms, bioburden events, media fill contamination, cross-area signals — the work is interpreting these as one connected picture rather than closing them out one deviation at a time, and turning that reading into contamination control decisions the site will act on.Three things are firm on this one. The work is investigative — reading and writing up what the microbial data is telling you, not running the sampling plan. A bachelor's degree in a scientific discipline is a hard requirement. And the job is onsite five days a week.Key ResponsibilitiesProvide technical support for assessment of microbial contamination events, EM excursions, personnel monitoring recoveries, bioburden events, sterility assurance signals, and recurring organism patternsPerform microbiological risk assessments covering aseptic processing, cleanroom operations, material transfer, cleaning and disinfection, utilities, interventions, personnel practices, and contamination control gapsReview microbial identification results and interpret organism source plausibility — human flora, water-associated organisms, spore-formers, environmental and objectionable organisms, and recurring isolatesSupport investigation of Grade A/B/C/D contamination events across EM data, personnel monitoring, process observations, cleaning history, maintenance activity, material flow, intervention records, and facility and utility conditionsPartner with QC Microbiology and the environmental monitoring group to identify adverse trends, recurring locations, recurring operators, recurring organisms, and cross-area contamination signals requiring escalation to the contamination control strategy, quality risk management, or site quality governanceSupport APS / media fill assessments — contamination events, intervention representativeness, personnel participation, recurring failure modes, and CAPA effectivenessHelp develop risk-based escalation criteria for EM and personnel monitoring trends, microbial IDs, contamination-related deviations, and repeat eventsReview contamination-related deviations and CAPAs to provide microbiological rationale, root cause input, risk impact assessment, and effectiveness‑check recommendationsContribute to periodic sterility assurance health summaries covering microbial risk signals, repeat contamination patterns, investigation quality, and CAPA effectivenessSupport development of site standards, decision trees, training content, and technical guidance for microbial contamination controlRequired QualificationsBachelor's degree or higher in microbiology, biology, biotechnology, pharmaceutical sciences, or a related scientific discipline — this is a hard requirement and relevant experience does not substitute5+ years in QC Microbiology, environmental monitoring, sterile manufacturing support, aseptic processing, contamination control, sterility assurance, or biologics / cell therapy manufacturingStrong working knowledge of environmental monitoring, personnel monitoring, microbial identification, bioburden, aseptic technique, cleanroom controls, and contamination investigationsExperience supporting GMP deviations, CAPAs, root cause analysis, risk assessments, and technical documentationAbility to interpret microbial data and translate findings into practical contamination control recommendationsStrong technical writing and cross‑functional communication skillsAble to work onsite in Berkeley, CA five days per weekPreferredGrade A/B aseptic processing in biologics, cell therapy, or sterile drug product operationsAPS / media fills, gowning qualification, operator monitoring, aseptic behavior observations, disinfectant efficacy, cleaning and disinfection programs, or contamination recovery investigationsFamiliarity with EU GMP Annex 1, FDA aseptic processing guidance, USP microbiology chapters, PDA technical reports, and ICH Q9/Q10Microbial source tracking, recurring organism assessments, objectionable organism rationale, or biofilm‑related investigationsWorking across QC Microbiology, Manufacturing, QA, Engineering, and Validation teamsBenefits (employee contribution)Health insuranceHealth savings accountVision insuranceFlexible spending accountsLife insuranceAll qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualifications of the applicant.#J-18808-Ljbffr