Quality Control Analyst at BioPharma… · Fort Worth

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