Quality Control - Microbiologist Job Listing at Kelly Services in Carlsbad, CA (Job ID US3561378_BH9814644)

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.

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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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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