What are the responsibilities and job description for the Quality Control Analyst II position at BioPharma Consulting JAD Group?
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
Education
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.
Education
- Bachelor's degree in Chemistry, Biochemistry, Biology or a related scientific field
- Capillary electrophoresis
- HPLC/GC
- Analytical instrument qualification
- 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
- Contract position: 12 months, with possible extension
- Shift: Administrative shift
- Days: Monday to Friday, 40 hours/week
- On-site in Fort Worth, Texas