Senior Quality Control Analyst

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.

NO C2C, Sponsorship or Third Party Agency

Location On-Site (mon-fri) Fort Worth Texas

Contract Duration: 6 months with potential extension

w2 hourly pay rate $38/hr - $43/hr

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:

Perform instrument qualification, write qualification protocols, execute qualification protocols specifically HPLC, HPIC (Ion Chromatography), UPLC, refrigerator, Mercury Analyzer, etc.

write SOPs, conduct training.

Conduct trouble shooting, investigation (CAPA and effectiveness).

resolve issues.

Perform PM/PV on various equipment, Osmometer, Viscometer, Turbidimeter, pH meter, Conductivity meter, Centrifuge, UV Spectrophotometer, Fluorescence Spectrophotometer, Rheometer, Karl Fischer, particle size analyzer, etc.

Write and review technical documents.

manage projects.

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