Quality Control Analyst III
6201 South Freeway Fort Worth, TX 76134 US
Job Description
Summary of Position:
This position, using in-depth knowledge of relevant guidance/regulatory documents, is responsible for analytical method validation & development/improvements/transfers, 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:
- Execute analytical method development, validation and method/product transfer protocols.
- Perform complex analysis of raw materials, finished goods, products, packaging components, complaints, investigations per schedule and per standards/SOPs as needed.
- Collect, calculate, interpret and trend test results.
- Enter and report test results.
- Write or review validation protocols and technical reports.
- Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation.
- 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.
BACKGROUND:
- Preferred candidates will have analytical method validation experience.
- Minimum requirements: Bachelors 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 2 Years of Relevant Experience
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