Description
Job Purpose:
To ensure product and process quality, regulatory compliance, and continuous improvement across manufacturing operations in the pharmaceutical and food industries through inspection, validation, documentation, and oversight activities.
Key Responsibilities:
- Perform inspections and audits for all manufacturing processes, documentation, and packaging to ensure compliance with standards, current specifications, quality agreements, and customer requirements
- Validate and calibrate laboratory and manufacturing equipment (pH meters, conductimeters, refractometers, balances, incubators, fillers, robots, Brix% meters, etc.)
- Manage and document the sampling of raw materials, in-process, and finished products using industry-accepted microbiology methods (e.g., 3M, petri dish inoculation)
- Review and approve batch records, track deviations, perform root cause analysis, and implement corrective actions
- Lead and participate in internal and external audits (FDA, OSHA, EPA, Department of Health), ensuring all processes meet regulatory and company requirements
- Execute and oversee good manufacturing practices (GMP), good documentation practices (GDP), Hazard Analyst duties under HACCP principles, and compliance with ISO 9001, FSMA, USDA, and other regulations
- Support environmental monitoring, validation, and release activities, including documentation and approval of cleaning and sanitization processes
- Train manufacturing employees in GMP, HACCP, and safety protocols
- Oversee maintenance, calibration, and troubleshooting for all laboratory and production equipment
- Collaborate on continuous improvement projects, process optimization, SOP documentation, and audit trail reviews
- Utilize and manage electronic quality systems and software (SAP, LIMS, EBR, Trackwise, ColdStream, TruVault, GMARS, MES/PAS-X, Syncade, Delta-V) for record-keeping and reporting
- Ensure accurate reporting of manufacturing data, metrics, and production rates; respond to product recall, complaints, and traceability requirements
- Communicate with Supply Chain, Disposition, and Production teams to align on priorities and maintain workflow efficiency and compliance
- Bachelor's Degree in Natural Sciences or related field
- Knowledge and experience in GMP, FSMA, USDA, HACCP, FDA, OSHA, EPA, ISO 9001 standards
- Experience with inspection, sampling, laboratory testing, equipment calibration, validation, and documentation
- Strong analytical, auditing, problem-solving, and leadership skills
- Proficiency with quality management systems, manufacturing software, and reporting tools
- Ability to train, supervise, and communicate with cross-functional teams
- Bilingual (Spanish-English) communication preferred
- Certifications in GMP, HACCP, and other relevant industry standards or practices
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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