Quality Control Analyst

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.

Laboratory Testing & Analysis:

• Conduct Laboratory Testing:
• 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.
• Ensure that all tests are performed accurately, using the appropriate equipment and analytical techniques.
• Analysis of Results:
• 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.
• Instrument Calibration and Maintenance:
• Ensure proper calibration, maintenance, and troubleshooting of laboratory equipment and instruments.
• Perform regular checks to ensure laboratory instruments are functioning properly and meet regulatory standards.

Documentation & Reporting:

• Maintain Accurate Records:
• 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.
• Ensure Compliance with GMP and SOPs:
• Adhere to GMP regulations, ensuring that all testing processes and results are compliant with internal and regulatory guidelines.
• Review and verify testing data for accuracy and completeness before submission for approval.

Deviation and Investigation Management:

• Support Investigations:
• 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 Test Failures:
• Report and document any deviations or discrepancies observed during testing promptly and follow through with investigations as required.
• Collaborate with the Quality Assurance (QA) team to ensure that all deviations are properly documented and addressed.

Quality Control Systems:

• Ensure Adherence to Quality Control Procedures:
• 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 continuous improvement of quality control processes and testing methodologies.
• Assist in Method Validation:
• Support the validation and verification of testing methods and procedures to ensure accuracy, reproducibility, and reliability of results.
• Assist with writing and reviewing method validation protocols and reports.

Compliance and Regulatory Support:

• Regulatory Inspections:
• Prepare for and participate in internal and external audits, including regulatory inspections by authorities such as the FDA, EMA, etc.
• Ensure that all documentation and testing procedures are compliant with GxP (Good Laboratory Practice, Good Manufacturing Practice) regulations.
• Maintain Compliance with Safety Guidelines:
• Follow safety guidelines and laboratory protocols to maintain a safe working environment, ensuring compliance with health and safety regulations.

Team Collaboration and Training:

• Collaborate with Team Members:
• Work closely with the QC, QA, and production teams to ensure seamless communication and collaboration in testing and resolving quality-related issues.
• Training:
• Provide training to junior analysts on laboratory procedures, safety standards, and GMP regulations.
• Stay up-to-date with changes in regulatory requirements, industry standards, and new technologies relevant to the role.

Requirements

Education:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Advanced degrees or certifications (e.g., HPLC, GC) are a plus.

Experience:

• 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.

Technical Skills:

• 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.

Attention to Detail:

• Strong attention to detail and accuracy when performing tests and documenting results.

Problem-Solving:

• Ability to troubleshoot issues in the laboratory and recommend solutions.

Communication Skills:

• Excellent written and verbal communication skills for documentation and report generation.
• Ability to effectively communicate findings and collaborate with other departments.

Benefits

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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