Quality Control Microbiologist II – 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.
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!
Essential job duties
• 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
Education, experience, certification and licensure
• Bachelor’s Degree in Microbiology or related field
• Minimum 3-5 years’ industry experience in a GMP sterile finish or pharmaceutical cleanroom environment
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>
• Strong organizational skills and the ability to prioritize/multitask
• Proficient in Microsoft Office Suite (excel)
• Attention to details and following GMP methods and instructions
• Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, and customers
• Ability to write reports, business correspondence, and procedures
• Ability to define problems, collect data, establish facts, and draw valid conclusions
Physical requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Work environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.
Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act.
Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.
Other Qualifications
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
Pay Range: $70,304-$88,000/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.