Quality Control Analyst

About the position

We are seeking a GMP QC Analyst to join our team. This role is responsible for performing quality control testing, ensuring the analysis of raw materials, in-process materials, and finished products in compliance with Good Manufacturing Practices (GMP) and regulatory standards. The QC Analyst will conduct laboratory testing, maintain accurate documentation, and support the overall quality assurance processes within the organization to ensure product safety, efficacy, and compliance with industry regulations.

Responsibilities

• Perform routine and non-routine testing of raw materials, in-process samples, and finished products following established testing methods, protocols, and GMP guidelines.
• Test for physical, chemical, and microbiological properties, including but not limited to HPLC, GC, UV/VIS spectroscopy, pH, titration, and stability studies.
• Analyze test results and report any deviations, discrepancies, or failures in the testing process.
• Evaluate data for trends and anomalies, reporting results to the Quality Control Manager for review and action.
• Ensure proper calibration, maintenance, and troubleshooting of laboratory equipment and instruments.
• Document all test results, observations, and deviations according to GMP and internal standard operating procedures (SOPs).
• Complete and maintain clear, accurate records of all testing and results, ensuring data integrity and compliance with 21 CFR Part 11 requirements.
• Assist in the investigation of out-of-specification (OOS) results, deviations, and non-conformance reports (NCRs) by performing root cause analysis.
• Support the implementation of corrective and preventive actions (CAPA) to address issues and prevent recurrence.
• Report and document any deviations or discrepancies observed during testing promptly and follow through with investigations as required.
• Follow internal Standard Operating Procedures (SOPs) for testing, reporting, and compliance, ensuring all activities are in line with GMP standards and applicable regulations.
• Support the validation and verification of testing methods and procedures to ensure accuracy, reproducibility, and reliability of results.
• Prepare for and participate in internal and external audits, including regulatory inspections by authorities such as the FDA, EMA, etc.
• Follow safety guidelines and laboratory protocols to maintain a safe working environment, ensuring compliance with health and safety regulations.
• Work closely with the QC, QA, and production teams to ensure seamless communication and collaboration in testing and resolving quality-related issues.
• Provide training to junior analysts on laboratory procedures, safety standards, and GMP regulations.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 2-3 years of experience in a Quality Control or laboratory testing role, ideally within the pharmaceutical, biotechnology, or life sciences industry.
• Experience in conducting laboratory tests such as HPLC, UV/VIS spectroscopy, and titration is preferred.
• Experience working in a GMP-regulated environment is required.
• Proficient in laboratory testing techniques and the use of laboratory equipment.
• Familiarity with data analysis software (e.g., Empower, LabWare), and the ability to perform trend analysis.
• Knowledge of regulatory requirements, including FDA, EMA, and GxP guidelines.
• Strong attention to detail and accuracy when performing tests and documenting results.
• Ability to troubleshoot issues in the laboratory and recommend solutions.
• Excellent written and verbal communication skills for documentation and report generation.

Nice-to-haves

• Advanced degrees or certifications (e.g., HPLC, GC).

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)