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 major medical device company in Fort Worth, Texas.
This is Not a Software Testing or Testing Automation position. We are looking for a Laboratory Chemist who has calibrated Lab instruments. and performed preventative maintenance.
Title: Quality Assurance Analyst II
Location: Fort Worth, TX
On-Site (Mon-Fri)
w2 Hourly: $44.28
Contract Duration: 6 months, with likely extension
No C2C, Sponsorship or Third Party Agency
Job Description:
This position, using in-depth knowledge of relevant guidance/regulatory documents, is responsible for instrument qualifications and applications (LIMS, Chromeleon, etc.), participate in product/process investigations as needed, ensuring required quality and safety standards are being met for our products and processes.
Key Responsibilities:
• Perform instrument preventive maintenance, performance verification per schedule and per standards/SOPs as needed.
• Perform instrument trouble shooting, support investigation per standards/SOPs as needed.
• Write or review validation protocols and technical reports.
• Review internal documents / external documents, make recommendation as needed.
• Collect, calculate, interpret, document and report test results per ALCOA principles.
• Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation, for validation projects, activities related to instrument qualification, for instrument lifecycle management include procurement, qualification, in-use, maintenance/calibration, performance review and retirement.
• Perform investigative testing to support laboratory investigations; participate in root cause analysis; lead and write laboratory investigations. Investigate laboratory quality issues and recommend sound corrective actions and resolution.
• Perform and review equipment calibration and maintenance; serve as instrument advocate.
• Identify appropriate lab instrumentation purchases; perform qualification/validation.
• Conduct peer review and approval of data collected by coworkers.
• Lead laboratory initiatives or programs.
• Train analysts on internal procedures and test methods.
• Perform statistical analysis.
• Utilize change control systems and Inventory management.
• Act as an SME for critical processes and testing.
• Lead day to day activities acting as a backup to the supervisor as needed.
• Support tracking and reporting laboratory performance metrics.
Minimum requirements:
• Chemistry background with experience in analytical instrumentation is a must.
• Lab experience is required.
• Bachelors in Chemistry is preferred - or 10 years minimum experience working in a lab.
• Self-driven, project oriented and troubleshooting skills are highly preferred.
