Source One is a consulting services company and we're currently looking for the following individual to work as a consultant to our direct client, a global medical device company
If interested please send me an updated resume, thank you
Job Title: Quality Assurance Analyst II
Location: On-site in Fort Worth TX 76134
Duration: ASAP to 6-months and can possibly be extended
IMPORTANT:
1) Must be local to Fort Worth TX 76134
2) Must have Medical Device / Lab Equipment / Lab Instrument experience
3) Must have Process experience with Qualification, Performance, Calibration, Test Methods/Testing, LIMS systems
4) Provide leadership and ensure standards for safety, regulatory (ISO, CFR, FDA), and process.
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 and 2 Years of Demonstrated Leadership Experience.
Chemistry background with experience in analytical instrument is a must. Self-driven, project oriented and troubleshooting are highly preferred.
Job Description:
This position, using in-depth knowledge of relevant guidance/regulatory documents, is responsible for instrument qualifications and applications (LIMS, Chromeleon), 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.
Best Regards,
Alan Naroden - Senior Recruiter
Source One Technical Solutions - A WBENC Certified Company