Quality Control Analyst II

BioPharma Consulting JAD Group; Fort Worth (TX); On-site; USD 60,000 - 86,000; Full time

Job summary

BioPharma Consulting JAD Group in Fort Worth, Texas seeks a Quality Control Analyst II to support laboratory testing, method development and quality operations at a manufacturing site.

You will conduct analyses, develop methods, review transfers and ensure data meets specifications. The role involves calibration and maintenance of lab equipment, and collaboration with contract labs and vendors on data quality and regulatory compliance.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology or a related field.
• Experience with GMP/GDP and quality control laboratory practices is preferred.
• Familiarity with method development, validation and transfer processes.

Responsibilities

• Conduct routine and non-routine analyses of materials and finished goods.
• Develop and qualify new testing methods; perform validations or transfers.
• Prepare or review method transfer documentation and reports.
• Interpret test results against specifications and control limits.
• Lead investigations of out-of-specification results and propose corrective actions.
• Write deviation reports, protocols, and trend analyses; update SOPs.
• Calibrate, validate and maintain laboratory equipment; troubleshoot issues.
• Coordinate testing with contract labs and vendors; review data for compliance.
• Support regulatory submissions with QC data; participate in internal audits.

Skills

Analytical method development

OOS investigations

Technical writing

Laboratory equipment calibration

GMP/GDP knowledge

Train others

Cross-functional collaboration

Vendor/contract lab coordination

Education

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

Tools

Capillary electrophoresis

HPLC/GC

Analytical instrument qualification

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