Quality Control Microbiologist (For Surgical)

Job Title: QA/QC Analyst

Job Overview:

As a QA/QC Analyst in our pharmaceutical company, you will be responsible for ensuring that all products meet our stringent quality standards. This role involves meticulous analysis, inspection, and testing of raw materials, intermediates, and finished products to ensure they comply with regulatory requirements, company standards, and industry best practices. The QA/QC Analyst will collaborate with cross-functional teams to identify and address quality issues, ensuring consistent and safe products reach the market.

Key Responsibilities:

• Perform physical, chemical, and microbiological testing of raw materials, intermediates, and finished products according to established protocols and procedures.
• Evaluate test results and compare them against established specifications to determine compliance.
• Conduct root cause analysis for any deviations or non-conformities and implement corrective and preventive actions as necessary.
• Review and approve documentation related to QA/QC activities, including batch records, specifications, and validation protocols.
• Support investigations into out-of-specification (OOS) results and assist in determining corrective actions.
• Develop, implement, and maintain quality control systems, including training programs, to ensure compliance with regulatory requirements and industry standards.
• Collaborate with cross-functional teams, including Production, R&D, and Regulatory Affairs, to resolve quality-related issues and ensure timely release of products.
• Maintain accurate and up-to-date records of QA/QC activities, ensuring data integrity and traceability.
• Assist in the preparation for and participation in regulatory agency inspections and audits.
• Identify areas for continuous improvement in quality control processes and procedures, recommending and implementing enhancements as appropriate.

Requirements:

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or a related field.
• Biomedical Engineers, Micro Biology, Chemist For Production and Mechanical Electric Supervisor / Production.
• Proven experience in a pharmaceutical QA/QC role, with a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations.
• Proficiency in analytical techniques such as HPLC, GC, FTIR, and microbiological methods.
• Excellent attention to detail and analytical skills.
• Strong organizational, communication, and problem-solving skills.
• Ability to work effectively in a team environment and collaborate with cross-functional teams.
• Familiarity with quality management systems (QMS) software and data analysis tools is a plus.
• Flexibility to work in a fast-paced, dynamic environment.