Quality Control Analyst

Quality Control Analyst Overview

• The Quality Control Analyst ensures high standards of quality and compliance throughout development and commercialization phases.
• Perform routine and non-routine testing, data trending, and investigations to support laboratory operations.
• Enhance efficiency and effectiveness of quality control processes through method transfers and validations.
• Support regulatory submissions, inspection readiness, and audits to maintain compliance standards.
• Contribute to continuous improvement initiatives and cross-functional collaboration within the organization.
• Maintain training records and support weekend lab operations as required.
• Assist in laboratory equipment and inventory maintenance, including reagent and sample preparation.
• Follow internal policies, SOPs, and regulatory standards such as GMP, GLP, and ICH guidelines.

Quality Control Analyst Key Responsibilities & Duties

• Perform analytical and microbiological assays for raw materials, in-process samples, product release, and stability studies.
• Review and qualify data in a timely manner, ensuring accuracy and compliance.
• Assist in updating controlled documents, including SOPs, work instructions, and test methods.
• Support method transfers, qualifications, validations, and implementations to enhance QC processes.
• Participate in environmental monitoring and in-process testing assignments.
• Contribute to regulatory submissions and inspection readiness activities.
• Collaborate with cross-functional teams to drive continuous improvement initiatives.
• Maintain laboratory equipment and inventory, ensuring operational efficiency.

Quality Control Analyst Job Requirements

• Bachelor’s degree in chemistry, biology, biochemistry, or a related field is required.
• 4-8 years of experience in GMP QC or equivalent within pharmaceutical/biotech industries.
• Proficiency in method transfer, implementation, and understanding of method lifecycle management preferred.
• Strong technical writing, data analysis, problem-solving, and organizational skills.
• Excellent communication and teamwork abilities to collaborate effectively.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.
• Knowledge of GMP, GLP, and ICH guidelines is essential for compliance.
• Ability to support weekend lab operations and maintain training records as needed.