QC Analyst II - Method Dev & Compliance

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

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.