QC Analyst II – Method Development & Compliance

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

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.