Quality Control Analyst II

Biopharma-Consulting-Jad-Group; Fort Worth (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Biopharma-Consulting-Jad-Group is seeking a Quality Control Analyst II for a Fort Worth, TX site to support laboratory testing, method development and quality operations.

The role involves analytical method development, method transfers, OOS investigations, and regulatory documentation. Requires a Bachelor's degree in a related science and hands-on GMP QC experience at a manufacturing site.

Qualifications

• Develop and qualify new testing methods; perform validations or transfers of analytical methods per policies/guidelines.
• Interpret test results against specifications and control limits; decide release suitability.
• Calibrate, validate and maintain laboratory equipment; troubleshoot issues.

Responsibilities

• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods and stability samples.
• Prepare or review method transfer documentation, including technical transfer protocols and reports.
• Participate in OOS and failure investigations; recommend corrective actions.
• Write technical reports and QC documentation such as deviation reports and SOPs.
• Coordinate testing with contract laboratories and vendors; review data for regulatory compliance.
• Supply QC data for regulatory submissions and internal audits.
• Train analysts on procedures; ensure lab cleanliness and safety standards.
• Evaluate new technologies and methods and propose improvements.

Skills

Method development

OOS investigations

Technical writing

GMP knowledge

Cross-functional work

Education

Bachelor's degree in Chemistry/Biochemistry/Biology or related

Job description

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.

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

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