Quality Control Analyst

Position Summary:

Quality Control Analyst performs various analyses, operates instruments according to approved procedures, and ensures compliance with cGMP and cGLP regulations. They contribute to maintaining accurate testing, adhering to lab SOPs, and supporting overall quality control processes.

Key Responsibilities:

• Perform various analyses in accordance with approved Test Procedures, Pharmacopeias, and Specifications.
• Operate instruments following approved Standard Operating Procedures (SOPs).
• Adhere to cGMP and cGLP regulations to ensure compliance with quality standards.
• Follow laboratory SOPs, systems, and policies to maintain consistency and accuracy.
• Present all reports, logbooks, and worksheets to the supervisor for review and approval.
• Implement instructions related to QC laboratory operations.
• Maintain cleanliness and organization of laboratory areas and equipment.
• Notify the supervisor immediately of any Out of Specification (OOS) results.
• Report any issues with out-of-service instruments or defects to the supervisor.
• Participate in training new employees to ensure a smooth onboarding process.
• Perform assigned tasks as directed by the supervisor.
• Utilize calibrated instruments and equipment and use valid reagents, solutions, and solvents.
• Follow the schedule set by the supervisor for efficient workflow management.
• Calibrate instruments, analyze working standards, and standardize volumetric solutions as requested by the supervisor.

Qualifications:

• Bachelor's degree in Chemistry, Pharmacy, or a related scientific discipline.
• Sound knowledge of analytical techniques, test procedures, and pharmacopeial standards.
• Familiarity with cGMP and cGLP regulations in the pharmaceutical industry.
• Experience working in a quality control laboratory, preferably within the pharmaceutical sector.
• Proficient in operating analytical instruments and following SOPs accurately.
• Strong attention to detail and accuracy in analyzing and recording data.
• Excellent understanding of laboratory safety protocols and good laboratory practices.
• Effective communication skills to collaborate with team members and report findings.
• Ability to work independently and manage multiple tasks with minimal supervision.
• Proficiency in using computer software and applications related to analytical testing and data analysis.

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