Quality Control Associate Job at Kelly, Gilroy, CA

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  • Kelly
  • Gilroy, CA

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; 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.

Job Tags

Local area, Shift work, Weekend work,

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