Quality Control (HPLC Certified)

Job Description:

Job Summary: We are seeking a highly skilled and experienced Quality Control Specialist with expertise in High-Performance Liquid Chromatography (HPLC) to join our pharmaceutical team. The ideal candidate will be responsible for ensuring the quality and safety of pharmaceutical products by conducting rigorous testing and analysis using HPLC and other analytical techniques. This role requires meticulous attention to detail, a strong understanding of pharmaceutical quality standards, and the ability to work in a fast-paced environment.

Key Responsibilities:

1. HPLC Testing and Analysis:

   • Perform routine and non-routine analysis of raw materials, in-process samples, and finished products using HPLC.
   • Develop, validate, and optimize HPLC methods in accordance with regulatory guidelines.
   • Troubleshoot and maintain HPLC equipment to ensure accurate and reliable results.

2. Quality Control Procedures:

   • Implement and follow standard operating procedures (SOPs) for quality control testing.
   • Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards.
   • Conduct stability testing of pharmaceutical products and monitor data for trends and deviations.

3. Documentation and Reporting:

   • Maintain accurate and detailed records of all testing and analysis in accordance with company and regulatory standards.
   • Prepare and review technical reports, Certificates of Analysis (CoAs), and other quality-related documents.
   • Assist in internal and external audits by providing documentation and explaining testing procedures.

4. Collaborative Efforts:

   • Work closely with other departments, such as Research and Development (R&D), Production, and Regulatory Affairs, to ensure product quality.
   • Provide training and guidance to junior staff on HPLC techniques and quality control practices.
   • Participate in cross-functional teams to address quality issues and implement corrective actions.

5. Continuous Improvement:

   • Identify opportunities for process improvements in the quality control laboratory.
   • Stay updated with the latest advancements in HPLC technology and pharmaceutical quality control standards.
   • Implement best practices to enhance the efficiency and accuracy of quality control operations.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Certification: HPLC certification is required; additional certifications in quality control or analytical techniques are a plus.
• Experience: Minimum of [X] years of experience in a pharmaceutical quality control laboratory, with extensive hands-on experience in HPLC.
• Technical Skills: Proficiency in HPLC method development, validation, and troubleshooting. Familiarity with other analytical techniques such as UV-Vis spectroscopy, GC, and FTIR is advantageous.
• Regulatory Knowledge: Strong understanding of GMP, GLP, ICH guidelines, and other relevant pharmaceutical regulations.
• Communication Skills: Excellent written and verbal communication skills, with the ability to document and present findings clearly.

Key Competencies:

• Attention to detail and accuracy in conducting tests and documenting results.
• Strong problem-solving skills and ability to troubleshoot analytical issues.
• Ability to work independently and as part of a team in a fast-paced environment.
• Commitment to maintaining high standards of quality and regulatory compliance.