Job Description

Quality Control - Microbiologist

Kelly® Science & Clinical is seeking a Microbiologist for a direct-hire position at a cutting-edge client in Carlsbad, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay : $27-32/hour

Schedule : Monday - Friday, 8 hours/day excluding lunch break. Overtime, weekends, and holidays may be required. Flexible start time between 6:00 am and 9:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Overview This client is an industry-leading company that’s leading the way in high-quality analytical testing services. As a Microbiologist, you will assist in establishing and managing a microbiology program that oversees aseptic fill/finish activities, environmental monitoring, gowning qualification, and the establishment of compendial microbiology assays that include endotoxin, bioburden, and sterility. The position is responsible for ensuring all activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and controls and drug product process validation is highly desired.

Responsibilities :

• Serve as a subject matter expert (SME) for microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits.
• Support assay transfer, qualification, and validation activities for microbial-based assays or client-specific methods.
• Author, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reports.
• Perform analysis on in-process samples, APIs, raw materials, and stability samples using existing methods.
• Perform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.
• Initiate and participate in the investigation of environmental monitoring excursions and assess potential impact on product quality.
• Support a Gowning Qualification Program for all manufacturing and QC personnel.
• Perform routine monitoring of pharmaceutical water and gas systems.
• Perform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testing.
• Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.
• Assist in trending EM data and generate quarterly and yearly reports.
• Participate in inspection readiness activities.
• Interact closely with other departments to ensure efficient, compliant, and timely execution of project activities.
• Provide assistance as needed to maintain a functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other duties.
• Assist in investigation and review of GMP quality events, including but not limited to deviations, non-conformances, and audit findings.
• Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results with a client-driven focus.
• Safely operate laboratory equipment in accordance with established practices and SOPs.
• Assist in training additional team members.
• Under minimum supervision, support special projects as needed.
• Operate to the highest ethical and moral standards.
• Adhere to quality standards set by regulations and client policies and procedures.
• Communicate effectively with supervisors, staff, and clients.
• Participate in projects within a team and as an individual.
• Support continuous improvement projects related to QC.
• Multi-task, prioritize workload, document properly, and interpret data accurately.
• Follow laboratory safety requirements to promote a safety-first culture.

Qualifications :

• BS in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences).
• Minimum three (3) years of experience in Quality Control and environmental monitoring of GMP facilities.
• High intelligence and problem-solving skills.
• Excellent oral and written communication and listening skills.
• High level of personal and professional integrity and trustworthiness with a strong work ethic

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What happens next : Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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