Quality Control AssociateKelly • Gilroy, CA, United States

Quality Control Associate

Kelly • Gilroy, CA, United States

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Kelly® Science & Clinical is seeking a Quality Control Associate for a direct hire opportunity with a leading pharmaceutical company in Gilroy, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Workplace : Onsite in Gilroy, CA

Position Title : Quality Control Associate

Position Type : Direct hire

Pay rate : $32 / hour

Schedule : Tuesday – Saturday, 10 : 00 pm to 6 : 00 am,

Overview

Join a leading pharmaceutical production team as a Quality Control Associate I, where you will play a key role in the synthesis and quality control of radiopharmaceuticals. This position allows you to operate advanced radiosynthesizers and analytical equipment, ensuring top-tier product quality and regulatory compliance in a high-paced, innovative environment.

Responsibilities

Production Operations

Conduct syntheses of FDG and NaF in strict compliance with Standard Operating Procedures (SOPs).
Verify all materials and reagents are accepted according to SOPs and are within expiry.
Ensure all equipment is appropriately qualified before use and assist with maintenance as needed.
Develop a working knowledge of the operational principles of synthesis units to support production reliability.

Quality Control

Perform thorough Quality Control testing of FDG and NaF batches using state-of-the-art instrumentation, following SOPs to guarantee product safety and efficacy.

Ensure calibration and qualification of all QC equipment prior to use and assist with ongoing maintenance activities.

Accurately complete cGMP documentation for all QC processes and support investigations and Corrective and Preventive Actions (CAPAs).

Compliance & Safety

Adhere strictly to relevant radiation safety programs and site-specific regulatory requirements.

Maintain qualification to access ISO-classified areas; conduct environmental monitoring and cleaning procedures for both classified and non-classified zones.

Consistently practice all radiation safety protocols in daily activities.

Inventory & Material Management

Monitor and replenish production, QC, and cleaning supplies; conduct material acceptance and inventory reporting in line with SOPs.

Operate basic computer-controlled cyclotron manufacturing for FDG and NaF under supervision or guidance as required.

Continuous Improvement & Collaboration

Communicate effectively to troubleshoot production, equipment, or QC issues with local and network support resources.

Report key manufacturing metrics to data systems as needed; collaborate with site and corporate Quality Assurance departments in investigations, deviations, atypical yields, logbooks, and quality activities.

Participate in internal meetings and perform additional duties as assigned, supporting operational excellence.

Qualifications

High School Diploma required; Associate’s degree in chemistry, engineering, or natural sciences preferred.

Technical experience with computer-controlled automation and analytical instrumentation preferred.

Proficiency with MS Office Suite and cGMP documentation standards.

Willingness to work various shifts, weekends, and up to 5% travel.

Strong attention to detail, organization, accountability, and teamwork in a regulated environment.

Professional communication skills and dependability in a technical setting.

What happens next?

Once you apply, you’ll proceed to the 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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Quality Control Associate • Gilroy, CA, United States