Sr. Lab Analyst, Quality Control

Sr. Lab Analyst, Quality Control

Baxter International

Marsa, Malta

The Sr. Laboratory Analyst is responsible for leading and supporting Quality laboratory activities to ensure compliance with applicable quality, regulatory, and operational requirements. Responsibilities include execution, review, trending, and oversight of laboratory testing activities, environmental monitoring programs where applicable, and support of product and process quality initiatives. The role may support microbiological, chemical, physical, or other laboratory testing disciplines based on business needs and area of assignment. The Sr. Laboratory Analyst is expected to demonstrate Good Laboratory Practice (GLP) principles, contribute to continuous improvement initiatives, support investigations and validations, and ensure compliance with Baxter quality standards.

Essential Duties and Responsibilities:

This position is responsible for ensuring that all laboratory activities are performed in accordance with Environmental Health and Safety requirements and Baxter quality standards.

Key responsibilities include:

• Performing, reviewing, trending, and supervising routine laboratory testing activities.
• Coordinating and managing laboratory testing schedules to ensure timely execution and reporting of results.
• Performing and reviewing analytical, microbiological, physical, chemical, and/or environmental testing as applicable to the assigned laboratory area.
• Supporting investigations related to laboratory results, deviations, non-conformances, and out-of-specification events.
• Supporting validation and qualification activities associated with laboratory methods, equipment, utilities, and manufacturing processes.
• Reviewing laboratory documentation and ensuring compliance with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
• Maintaining laboratory equipment, materials, and work areas in a compliant, organized, and inspection-ready state.
• Managing laboratory inventory and supporting procurement of laboratory supplies and equipment.
• Preparing, reviewing, and maintaining controlled documents, including SOPs, protocols, reports, and work instructions.
• Participating in continuous improvement projects and operational excellence initiatives.
• Providing technical guidance and training to laboratory personnel where required.
• Supporting product disposition and batch release activities through review of applicable laboratory and quality records.
• Ensuring routine work is conducted in a manner that protects personnel, facilities, products, and the environment.
• Reporting observed Health and Safety risks or quality issues to the appropriate management representative.
• Performing additional laboratory or quality-related duties as assigned.

Education and Experience:

Experience working within a Quality Control laboratory environment is required. Experience in analytical, chemical, microbiological, environmental monitoring, or other regulated laboratory disciplines is preferred. Knowledge of laboratory techniques, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and quality systems is essential.

Qualifications:

Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Life Sciences, Engineering, or a related scientific discipline. Relevant experience within a regulated manufacturing, pharmaceutical, medical device, or laboratory environment is preferred.