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Quality Control Microbiologist III - Camarillo, CA

The Quality Control Microbiologist III performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We proudly offer

    Generous benefit options (eligible first day of employment) 
    Paid training, vacation and holidays (vacation accrual begins on first day of employment)
    Career advancement opportunities 
    Education reimbursement
    401K program with matching contributions
    Learning platform
    And more!

Responsibilities

    Lead and/or support quality event investigations for out-of-specification (OOS), out-of-trend (OOT) or nonconformance events 
    Perform environmental monitoring of clean rooms (under ISO and EU specifications)
    Perform and review QC testing (Endotoxin, Bioburden, TOC, Conductivity, Growth Promotion Assay, etc.) for manufacturing, raw materials, in-process materials, intermediates and final product
    Demonstrate technical proficiency in test procedures and ensure QC activities are carried out using applicable regulatory requirements (FDA, USP, ICH etc.)
    Participate in audits, client investigations, and project-related activities
    Lead and/or support activities associated with Change Control, CAPAs, client audit response, work orders, etc.
    Receive and process samples to meet production/client timelines
    Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
    Prepare and send out samples for microbiological identification
    Ensure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are met
    Work closely and collaborate in a team environment with QC Analytical and Quality Assurance, Manufacturing, Technical Services, Materials Receiving, and Research and Development
    Ensure the successful implementation and execution of new QC methods/procedures and equipment
    Perform trending of QC data and present information to Management
    Perform general laboratory housekeeping
    Author, review, and approve microbiology test results and analytical methods as needed
    Ensure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are met
    Support Manufacturing with client-specific testing requirements
    Inspection of media fills

Qualifications

    Bachelor's Degree in Microbiology or related field
    Minimum 5+ years' industry experience in a GMP sterile finish or pharmaceutical cleanroom environment  
    Willing to work flexible hours (nights and weekends), as-needed

Knowledge, skills and abilities

    Proficient in the validation/qualification of lab microbiological techniques preferred
    Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
    Knowledgeable in USP <61>, <62>, <71>, and <85>
    Attention to details and following GMP methods and instructions

Other Qualifications

    Must pass a background check
    Must pass a drug screen
    May be required to pass Occupational Health Screening
    May be required to obtain and maintain gowning certification 
    May be required to obtain and maintain media qualification

Pay Range: $84,000-$105,600/year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.