Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant for our direct client, a global medical device company in Fort Worth, TX.
Job Title: Quality Control Analyst I (Contract)
Pay Rate: $25/hr (W-2)
Duration: 12 months
40 hours/week, Mon-Fri
Job Description:
• Ensure that lab cleanliness and safety standards are maintained.
• Develop and qualify new testing methods.
• Train other analysts to perform laboratory procedures and assays.
• Perform visual inspections of finished products.
• 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.
• Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• 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.
Required Skills:
• Laboratory & analytical skills (e.g., wet chemistry, analytical testing, assays) and an understanding of instrumentation (calibration, maintenance, troubleshooting)
• GMP/Regulatory Compliance exposure
• Documentation skills
• Problem solving & investigation skills
• Attention to detail & data integrity
• Bachelor's degree preferred