Job Description

Quality Control Microbiologist III - Camarillo, CA

The Quality Control Microbiologist II 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.

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 , , , and
• 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.