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: up to $40.00 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.