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 medical device manufacturing client in Fort Worth, TX.
This role will be onsite and available to candidates local to the Fort Worth, TX area, We are unable to work with third parties, corps or sponsor visas.
Title: Quality Control Analyst II
Location: Fort Worth, TX
Onsite (Mon-Fri, 40 hours)
Contract Duration: 12 months, with likely extension
Pay Rate: $40.00 per hour (w2)
Job Description:
Experience with laboratory instrumentation:
Experience with new instrument qualification
Performance maintenance/calibrating/verification
Assist QC lab with common troubleshooting
Vendor liaison
Ensure that lab cleanliness and safety standards are maintained. • Participate in internal assessments and audits as required.
• Identify and troubleshoot equipment problems.
• Evaluate new technologies and methods to make recommendations regarding their use.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• Coordinate testing with contract laboratories and vendors.
• Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
• Write or revise standard quality control operating procedures. • Supply quality control data necessary for regulatory submissions. • Receive and inspect raw materials.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Investigate or report questionable test results.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Identify quality problems and recommend solutions.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Calibrate, validate, or maintain laboratory equipment.
• Compile laboratory test data and perform appropriate analyses.
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
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