Quality Control Analyst II

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global ophthalmic manufacturing client in Fort Worth, TX.

No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Temporary Authorization

Title: Quality Control Analyst II

Location: Fort Worth, TX

Onsite (Mon-Fri, 40 hours)

Contract Duration: 12 months, with likely extension

Pay Rate: $40.00 - $45.00 per hour (w2)

This is an excellent opportunity for a QC professional with strong laboratory instrumentation experience who enjoys working in a highly regulated environment focused on quality, compliance, and continuous improvement.

Position Summary

We are seeking a Quality Control Analyst II to support laboratory operations, analytical testing, instrumentation qualification, and quality compliance activities within a regulated life sciences environment.

MUST HAVE - This role will focus on laboratory instrumentation preventive maintenance (PM), performance calibration (PC), performance verification (PV), equipment qualification, and implementation of new laboratory systems. Experience with Computer Software Assurance (CSA) and Computer System Validation (CSV) is highly preferred.

Key Responsibilities

• Perform routine and non-routine testing of raw materials, in-process materials, stability samples, environmental samples, and finished products.

• Support analytical method qualification, validation, and transfer activities.

• Calibrate, maintain, troubleshoot, and qualify laboratory equipment and instrumentation.

• Lead and support Preventive Maintenance, Performance Calibration, and Performance Verification activities for laboratory systems.

• Review, analyze, and interpret test results to ensure compliance with specifications and quality standards.

• Investigate deviations, OOS results, and equipment-related issues while supporting CAPA activities.

• Author and revise SOPs, protocols, reports, and other quality documentation.

• Coordinate testing activities with contract laboratories and external vendors.

• Participate in audits, inspections, and continuous improvement initiatives.

• Train laboratory personnel on procedures, equipment, and best practices.

Required Qualifications

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

• 3 years of Quality Control laboratory experience in a pharmaceutical, biotechnology, medical device, or regulated manufacturing environment.

• Experience with laboratory instrumentation, analytical testing, and quality systems.

• Strong technical writing, troubleshooting, and problem-solving skills.

• Working knowledge of GMP and regulatory compliance requirements.

Preferred Qualifications

• Experience with equipment qualification and validation programs.

• Hands-on experience supporting PM, PC, and PV activities.

• Knowledge of CSA and CSV methodologies.

• Experience with method validation, method transfer, and laboratory investigations.

• Familiarity with LIMS, Empower, TrackWise, or similar laboratory systems.