Quality Control Associate II

The Quality Control Analyst II is responsible for performing routine and non-routine laboratory testing of raw materials, in-process materials, finished products, environmental samples, and stability samples. This role supports product quality, regulatory compliance, laboratory investigations, method validation, and continuous improvement initiatives while ensuring adherence to established procedures, quality standards, and safety requirements.

Key Responsibilities

• Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, environmental samples, and stability samples.
• Interpret test results and determine compliance with established specifications, procedures, and quality standards.
• Ensure laboratory cleanliness, safety, and compliance with applicable regulations and company policies.
• Investigate out-of-specification (OOS), out-of-trend (OOT), invalid results, and laboratory deviations, and recommend corrective and preventive actions.
• Review analytical data for accuracy, completeness, and regulatory compliance.
• Develop, validate, transfer, and qualify analytical methods in accordance with internal procedures and regulatory guidelines.
• Prepare and execute method validation, verification, and transfer protocols and reports.
• Calibrate, maintain, troubleshoot, and verify laboratory equipment to ensure reliable operation.
• Identify and resolve laboratory equipment issues and coordinate repairs when necessary.
• Support internal audits, regulatory inspections, and quality assessments.
• Generate technical reports, deviation investigations, trend analyses, protocols, and laboratory documentation.
• Write, review, and revise standard operating procedures (SOPs), test methods, and work instructions.
• Coordinate testing activities with external laboratories, vendors, and contractors.
• Review third-party laboratory data and reports for accuracy, completeness, and compliance.
• Receive, inspect, and document incoming raw materials and laboratory supplies.
• Analyze laboratory data and perform statistical trending to identify quality risks and improvement opportunities.
• Identify quality issues, recommend solutions, and support continuous improvement initiatives.
• Train and mentor laboratory personnel on analytical techniques, procedures, and compliance requirements.
• Serve as a technical resource for Quality Control and cross-functional teams.
• Support preparation of quality control documentation required for regulatory submissions.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 3 years of Quality Control laboratory experience in a pharmaceutical, biotechnology, medical device, food, or related regulated industry.
• Experience working in a GMP/GLP-regulated environment.
• Hands-on experience with analytical testing, method validation, method transfer, and laboratory investigations.
• Knowledge of OOS, OOT, CAPA, and deviation management processes.
• Experience reviewing laboratory data and technical documentation.
• Strong problem-solving, troubleshooting, and analytical skills.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience supporting FDA, ISO, or other regulatory audits and inspections.
• Knowledge of statistical data analysis and trending techniques.
• Experience coordinating activities with contract laboratories and external vendors.
• Previous experience training or mentoring laboratory personnel.
• Familiarity with LIMS, Empower, SAP, LabWare, or similar laboratory systems.