Quality Control Analyst Ii

Overview

• Support quality and compliance efforts from development to commercialization within a regulated laboratory setting.
• Perform routine and non-routine microbiological assays to ensure product quality and compliance.
• Contribute to laboratory operations, including equipment maintenance and inventory management.
• Participate in data trending, investigations, and controlled document updates.
• Collaborate with cross-functional teams to align quality control operations with organizational goals.
• Support inspection readiness activities and onsite audits as required.
• Contribute to continuous improvement initiatives enhancing laboratory efficiency and effectiveness.
• Ensure adherence to internal standards, policies, and regulatory guidelines.

Key Responsibilities & Duties

• Perform microbiological assays, including bioburden, TOC, endotoxin, and conductivity testing.
• Maintain accurate training records and adhere to testing schedules.
• Assist in laboratory equipment maintenance and inventory management.
• Review and submit data promptly to ensure efficient operations.
• Contribute to controlled document updates, including SOPs and test methods.
• Participate in quality events such as investigations, deviations, and CAPAs.
• Collaborate with manufacturing, materials management, and quality assurance teams.
• Support onsite audits and inspections, ensuring compliance with regulatory standards.

Job Requirements

• Bachelor’s degree in biology, biochemistry, chemistry, or related scientific field.
• Minimum of 2 years of experience in a regulated laboratory setting or equivalent.
• Proficiency in microbiology testing and environmental monitoring sampling.
• Experience with quality events such as investigations, deviations, and CAPAs preferred.
• Knowledge of LIMS, Excel, Word, and PowerPoint is advantageous.
• Strong attention to detail and ability to adapt to shifting priorities.
• Effective communication and teamwork skills in a collaborative environment.
• Adherence to GMP, GLP, and ICH guidelines ensuring compliance and quality.