QC Microbiologist II

Overview

Quality Control Microbiologist II – Camarillo, CA

The Quality Control Microbiologist II performs quality activities in support of product production and releases. The QC Microbiologist conducts testing, trending, and reporting results to ensure compliance with applicable regulatory requirements.

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!

• 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
• Support Manufacturing with client-specific testing requirements
• Inspection of media fills

• Bachelor’s Degree in Microbiology or related field
• Minimum 3-5 years’ industry experience in a GMP sterile finish or pharmaceutical cleanroom environment
• Willing to work flexible hours (nights and weekends), as-needed

• 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
• 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

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…