Quality Control Analyst

Biopharma-Consulting-Jad-Group

Fort Worth (TX)

On-site

USD 55,000 - 85,000

Full time

13 days ago

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Job summary

Biopharma-Consulting-Jad-Group is seeking a Quality Control Analyst in Fort Worth, TX. The role performs analytical testing, data integrity, and collaboration across teams to support product release and regulatory submissions.

You will develop and validate methods, coordinate with external labs, and maintain instruments while ensuring compliance and accuracy of results.

Qualifications

  • Bachelor's degree in Chemistry, Biology, or related scientific discipline.
  • GMP/GLP environments experience preferred.
  • Strong analytical, problem-solving, and documentation skills.
  • Proficiency with laboratory instrumentation and data systems.

Responsibilities

  • Conduct routine and non-routine analyses of raw materials, in-process samples, finished goods, environmental samples, and stability batches.
  • Perform visual inspections of finished products to verify conformance to specifications.
  • Monitor testing procedures to ensure analyses follow established methods and protocols.
  • Investigate out-of-spec results and support corrective actions.
  • Compile laboratory data, perform trend analyses, and interpret results for release.
  • Develop, optimize, and qualify new analytical testing methods.
  • Validate methods and perform method transfers per guidelines.
  • Prepare transfer documentation, protocols, and technical reports.
  • Evaluate new technologies and recommend improvements.
  • Write and revise SOPs for quality control processes.
  • Prepare deviation reports, testing protocols, and regulatory support data.
  • Complete documentation for testing activities and equipment logs.
  • Review data from contract labs for accuracy and compliance.
  • Calibrate, validate, troubleshoot, and maintain laboratory instruments.
  • Identify and resolve equipment issues to minimize downtime.
  • Receive, inspect, and verify raw materials for specs.
  • Serve as liaison between Quality Control and internal/external partners.
  • Coordinate testing with external labs to ensure timely results.
  • Participate in internal assessments and audits.
  • Train junior analysts on procedures and standards.

Skills

Analytical testing
Problem solving
Documentation
Attention to detail
Team collaboration

Education

Bachelor's degree in Chemistry or Biology

Tools

Analytical instruments
Chromatography
Spectroscopy
LIMS / data systems

Job description

The Quality Control Analyst is responsible for performing analytical testing, maintaining laboratory compliance, supporting method development, and ensuring the accuracy and integrity of data used for product release and regulatory submissions. This role requires strong technical expertise, attention to detail, and the ability to collaborate effectively with internal teams, vendors, and contract laboratories.

Key Responsibilities
  • Conduct routine and non-routine analyses of raw materials, in-process samples, finished goods, environmental samples, and stability batches.
  • Perform visual inspections of finished products to verify conformance to specifications.
  • Monitor testing procedures to ensure all analyses follow established specifications, standard test methods, and approved protocols.
  • Investigate questionable, out-of-specification, or atypical results and support failure investigations with recommended corrective actions.
  • Compile laboratory test data, perform trend analyses, and interpret results to determine suitability for release.
  • Develop, optimize, and qualify new analytical testing methods.
  • Perform method validations and method transfers in accordance with applicable guidelines and policies.
  • Prepare or review method transfer documentation, including protocols and technical reports.
  • Evaluate new technologies, instruments, and analytical approaches; provide recommendations for adoption or improvement.
  • Write and revise standard operating procedures (SOPs) for quality control processes.
  • Prepare technical documentation such as deviation reports, testing protocols, trend analyses, and regulatory support data.
  • Complete all required documentation for testing activities, including data capture forms, equipment logbooks, and inventory records.
  • Review data generated by contract laboratories to ensure accuracy, completeness, and regulatory compliance.
  • Calibrate, validate, troubleshoot, and maintain laboratory instruments and equipment.
  • Identify and resolve equipment issues to minimize downtime and ensure testing continuity.
  • Receive, inspect, and verify raw materials for compliance with specifications.
  • Serve as a technical liaison between Quality Control and internal departments, external vendors, and contract laboratories.
  • Coordinate testing activities with external laboratories and vendors to ensure timely and accurate results.
  • Participate in internal assessments and audits as required.
  • Train junior analysts on laboratory procedures, assays, and quality standards.
  • Bachelor's degree in Chemistry, Biology, or a related scientific discipline.
  • Experience in GMP/GLP environments preferred.
  • Strong analytical, problem-solving, and documentation skills.
  • Proficiency with laboratory instrumentation and data systems.
  • High attention to detail and commitment to quality and compliance.
  • Location: Fort Worth, TX (Onsite)
  • Duration: 12 months contract
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