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Quality Assurance Analyst II

3 months ago

Fort Worth, United States TalentBurst, an Inc 5000 company Full time

Industry: Medical Devices

Title: Quality Assurance Analyst II

Job ID: 2985-1

Location: Fort Worth, TX

Duration: 06 months (+Possibilities of extension)


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:

Bachelor's Degree or Equivalent years of directly related experience or high school +16 yrs; Assoc.+10yrs; M.S & PhD.+0 yrs) The ability to fluently read, write, understand and communicate in English 10 Years of Relevant Experience 2 Years of Demonstrated Leadership Chemistry background with experience in analytical instrument is a must. Sefl-driven, project oriented and troubleshooting are highly preferred.