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Open nowPosted 10 days ago

Quality Control Analyst II

Workable (global search)108,016 open roles

Where
Fort Worth, TX, United States
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Your applicationOpen nowQuality Control Analyst IIWorkable (global search) · Fort Worth, TX, United States

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The clock on this job

Early applications get read.

7.9% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 7 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 7.9%7 days
  4. 14.9%14 days
  5. 34.0%30 days
This job: posted 10 days ago

Workable (global search) median: 7 days open

The posting

We are seeking a Quality Control Analyst II to support laboratory testing, method development and quality operations at a manufacturing site in Fort Worth, Texas.

Key Responsibilities

  • Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods and stability samples.
  • Develop and qualify new testing methods; perform validations or transfers of analytical methods per applicable policies and guidelines.
  • Prepare or review method transfer documentation, including technical transfer protocols and reports.
  • Interpret test results against specifications and control limits and recommend whether data is appropriate for release.
  • Participate in out-of-specification (OOS) and failure investigations and recommend corrective actions; investigate or report questionable results.
  • Write technical reports and documentation such as deviation reports, testing protocols and trend analyses; write or revise QC standard operating procedures.
  • Calibrate, validate and maintain laboratory equipment; identify and troubleshoot equipment problems.
  • Receive and inspect raw materials and perform visual inspections of finished products.
  • Coordinate testing with contract laboratories and vendors, and review their data for accuracy and regulatory compliance.
  • Supply QC data for regulatory submissions and participate in internal assessments and audits.
  • Serve as technical liaison between Quality Control and other departments, vendors or contractors.
  • Train other analysts on laboratory procedures and assays; ensure lab cleanliness and safety standards are maintained.
  • Evaluate new technologies and methods and recommend improvements to analytical procedures.

Requirements

Education

  • Bachelor's degree in Chemistry, Biochemistry, Biology or a related scientific field

Preferred Experience

  • Capillary electrophoresis
  • HPLC/GC
  • Analytical instrument qualification

Key Skills

  • Analytical method development, qualification, validation and transfer
  • OOS/deviation investigations and root cause analysis
  • Technical writing: protocols, reports, SOPs and trend analyses
  • Laboratory equipment calibration, maintenance and troubleshooting
  • Knowledge of GMP/GDP and regulatory compliance in a quality control laboratory
  • Ability to train others and work cross-functionally with vendors and contract laboratories

Benefits

  • Contract position: 12 months, with possible extension
  • Shift: Administrative shift
  • Days: Monday to Friday, 40 hours/week
  • On-site in Fort Worth, Texas
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