Quality Control Operations Analyst Ii

Overview

• Contribute to maintaining high standards of quality and compliance in pharmaceutical development and commercialization processes.
• Perform routine and non-routine analytical and microbiological assays for raw materials, in-process samples, and product stability studies.
• Support method transfers, qualifications, validations, and implementations to enhance efficiency and effectiveness in Quality Control operations.
• Participate in data trending, investigations, and continuous improvement initiatives within the Quality Control department.
• Collaborate cross-functionally to ensure compliance with internal policies, SOPs, and regulatory standards.
• Engage in regulatory submissions, inspection readiness, and audits to maintain operational excellence.
• Provide weekend lab coverage and support lab operations, including equipment maintenance and inventory management.
• Contribute to updating controlled documents such as SOPs, work instructions, and test methods.

Key Responsibilities & Duties

• Perform analytical and microbiological assays following established SOPs for product release and stability studies.
• Maintain training records and support weekend lab operations as required.
• Assist in lab equipment maintenance, reagent preparation, and sample processing tasks.
• Review and qualify data in a timely manner, ensuring accuracy and compliance.
• Participate in operational assignments, including raw material processes and environmental monitoring.
• Collaborate on updating controlled documents and adhering to regulatory standards.
• Support regulatory submissions and inspection readiness activities.
• Engage in continuous improvement initiatives and cross-functional collaboration to enhance QC operations.

Job Requirements

• Bachelor of Science in chemistry, biology, biochemistry, or related field required.
• 4-8 years of experience in GMP Quality Control within the pharmaceutical or biotech industry.
• Proficiency in method transfer, implementation, and lifecycle management preferred.
• Strong technical writing, data analysis, and problem-solving skills essential.
• Excellent communication and teamwork abilities required.
• Experience with LabWare LIMS and Microsoft Office applications preferred.
• Ability to work onsite and provide weekend coverage as needed.
• Knowledge of GMP, GLP, and ICH regulatory standards essential.