Quality Control Specialist

Responsibilities

• Oversee systems supporting GMP stability programs including tracking and trending of stability data, generation of protocols and reports, and driving timely completion of quality records
• Maintain stability testing records and results within the stability software to assure traceability and availability of records
• Collaborate with contract laboratories to ensure timely completion of testing and delivery of QC deliverables for stability programs
• Review and approve laboratory data and results, ensuring their traceability and integrity
• Generate and present stability metrics to support annual reports, regulatory filings, and internal decision-making
• Perform routine trending of stability data to support shelf-life of GMP products
• Evaluate product stability data to establish and extend product shelf-life
• Coordinate shipping and sample management of routine and non-routine testing activities
• Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
• Create and improve procedures related to GMP stability programs
• Support batch certificate and Certificates of Analyses generation and additional tasks as required
• Participate in the authoring and review of QC protocols and stability reports

Qualifications And Experience

• BS in a scientific area with 3-5 years of experience in Quality Control in a GMP setting
• Working knowledge of statistical tools, methodologies, and related software, including experience with JMP as a plus
• Experience working with contract testing laboratories or external vendors in a regulated environment
• Ability to review analytical data for completeness, accuracy, traceability, and compliance with applicable procedures
• Effective verbal and written communication skills
• Proven ability to work with a high level of integrity, accuracy, and attention to detail
• Familiarity with ICH stability guidelines and expectations for pharmaceutical products
• Knowledge of quality systems and domestic and international regulatory requirements