Job Description

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; Associates 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, youll proceed to the next steps if your skills and experience look like a good fit. But dont worry even if this position doesnt work out, youre 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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