55 applicantsPosted by Agency
Source One Technical Solutions ยท 4 days ago
Quality Assurance Analyst II
Fort Worth, TX
Contract
Onsite
Senior Level
10+ years exp
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Hiring Manager
Alan Naroden
Insider Connection @Source One Technical Solutions
Responsibilities
Perform instrument preventive maintenance, performance verification per schedule and per standards/SOPs as needed.
Perform instrument troubleshooting, support investigation per standards/SOPs as needed.
Write or review validation protocols and technical reports.
Review internal documents / external documents, make recommendations as needed.
Collect, calculate, interpret, document, and report test results per ALCOA principles.
Write and take ownership of SOPs related to testing programs, laboratory operations, and/or equipment operation, for validation projects, activities related to instrument qualification, for instrument lifecycle management including 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 resolutions.
Perform and review equipment calibration and maintenance; serve as an 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.
Qualification
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Required
Must be local to Fort Worth TX 76134
Must have Medical Device / Lab Equipment / Lab Instrument experience
Must have Process experience with Qualification, Calibration, Test Methods, LIMS systems
Ensure standards for safety, regulatory (ISO, CFR, FDA), processes
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
Preferred
Self-driven, project oriented and troubleshooting are highly preferred
Company
Source One Technical Solutions
Source One Technological Solutions is a specialist consultancy provider in the fields of information technology, research and engineering.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
