Lab Tech II

The Fountain Group is a national staffing firm and we are currently seeking a ­­­­­­­­QC Chemist for a prominent client of ours.  This position is in Irvine, CA 92612 Details for the position are as follows:

Quality Control Chemist / QC Analyst

Pay: $26–$28/hour
Duration: 2-Year Contract
Schedule: 100% Onsite

Position Overview

We are seeking a Quality Control Chemist / QC Analyst to support routine laboratory testing within a cGMP-regulated pharmaceutical/biotechnology environment. This position will perform analytical testing using techniques including HPLC, Gas Chromatography (GC), and Capillary Electrophoresis (CE) while ensuring compliance with laboratory data integrity and documentation requirements.

The ideal candidate will have hands-on analytical laboratory experience and a strong understanding of cGMP requirements, laboratory investigations, deviations, CAPAs, and Out-of-Specification (OOS) results.

Key Responsibilities

• Perform routine chemical and laboratory testing using HPLC, Gas Chromatography (GC), Capillary Electrophoresis (CE), UV analysis, and other analytical techniques

• Complete in-process sampling and testing accurately and within established timelines

• Maintain complete, accurate, and compliant laboratory records in accordance with cGMP and data integrity requirements

• Own and support quality system records related to deviations, laboratory investigations, CAPAs, Change Controls, and OOS results

• Participate in analytical method transfers and method validations

• Support the qualification and implementation of new laboratory equipment

• Ensure laboratory instruments and equipment are properly operated, maintained, and documented

• Author and review laboratory documentation, including SOPs, protocols, reports, and test methods

• Assist with troubleshooting and resolution of laboratory and quality issues

• Support new product transfers and other laboratory initiatives as needed

• Perform routine laboratory activities including waste disposal, glasswasher operation, autoclave runs, and inventory management

• Maintain accurate inventory records for regulated materials and toxins

• Follow all applicable Environmental, Health & Safety (EHS), quality, and regulatory procedures

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline

• Minimum 3 years of laboratory experience

• Hands-on experience with HPLC analytical methods

• Experience with Gas Chromatography (GC)

• Knowledge or experience with Capillary Electrophoresis (CE)

• Experience working in a cGMP-regulated laboratory environment

• Experience supporting laboratory investigations, deviations, CAPAs, Change Controls, and/or OOS results

• Strong laboratory documentation and data integrity practices

• Ability to work independently while effectively collaborating with laboratory colleagues, management, and cross-functional teams

• Strong attention to detail, organization, and ability to manage multiple priorities

Additional Requirements

• Must be comfortable working in areas requiring Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3)procedures and regulated select-agent/toxin access

• Must be able to comply with all applicable federal and company requirements related to select agents and toxins

• Ability to wear a respirator for extended periods, potentially 4+ hours during production activities

• Ability to perform physical laboratory activities including lifting, carrying equipment, pushing carts, and frequent movement throughout the workday

• Must be flexible to work overtime, weekends, holidays, and non-standard hours as required by the manufacturing schedule

Preferred Qualifications

• Pharmaceutical, biotechnology, or other regulated industry experience

• Experience with analytical method transfers and validations

• Experience with laboratory equipment qualification

• Experience authoring or revising SOPs, test methods, protocols, and technical reports
  
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