QC Associate

The Fountain Group; Fremont (CA); On-site; USD 39,000 - 52,000; Full time

Job summary

The Fountain Group in Fremont, CA is seeking a QC Analyst to provide routine and non-routine testing in a multi-product QC laboratory, ensuring timely, accurate results and compliance with cGMP. You will review data, interpret results, and support investigations while maintaining rigorous documentation and safety standards.

The role requires 3-5 years of industry experience, GMP familiarity, and proficiency with LIMS, Veeva, and GoTrack. Bachelor's degree in Biology or Life Sciences is required.

Qualifications

• 3-5 years of industry experience.
• GMP experience is highly preferred.

Responsibilities

• Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.
• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
• Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activities.
• Assist with implementing Client improvements and new ways of thinking toward lab processes and compliance activities.
• Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
• Provide support during audits and inspections.

Skills

Industry experience

GMP experience

Education

Bachelor's degree in Biology or Life Sciences

Tools

LIMS

Veeva

GoTrack

Job description

Pay: $33.19/Hour

Duration: 6+ months

1st Shift: Mon-Fri, 9AM-5PM

Overview

• Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.
• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
• Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activities.
• Assist with implementing Client improvements and new ways of thinking toward lab processes and compliance activities.
• Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
• Provide support during audits and inspections.
• Work independently with adequate training and background of fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, Osmolalilty, Microbiology and more.
• Review of analytical results within timeline right the first time.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification.
• Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments

Skills

• 3-5 years of industry experience
• GMP experience is highly preferred
• System familiarity that would be helpful: LIMS, Veeva & GoTrack

Education

• Bachelors' degree in Biology or Life Sciences required.

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