Job Description
Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

QUALIFICATIONS & EXPERIENCE

• Bachelor’s degree in Science/ Life Science, Pharmaceutical Science, Engineering or proven relevant experience.
• 2 to 3 years of applied professional work experience in the quality laboratory

REQUIRED SKILLS:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Bioburden Testing, Biopharmaceutical Industry, Biopharmaceutics, Calibration Management Software, Calibration of Equipment, Chemical Analysis, Data Analysis, Environmental Monitoring, GMP Compliance, Karl Fischer Titrations, Laboratory Analysis, Laboratory Instrumentation, Laboratory Techniques, Management Process, Microbiology Research, New Product Introduction (NPI), New Product Introduction Process, Pharmaceutical Sciences, Quality Control Management, Standards Compliance {+ 4 more}

The position of Associate Specialist in Value Stream (VSM) Laboratory will be responsible for ensuring and maintaining high standards of quality and compliance within our organization.

In this role, you will be responsible for all or subset of the key responsibilities below:

• Perform analytical testing of incoming materials, in-process samples, cleaning samples, environmental monitoring samples, utility systems, intermediates and finished drug substances/ products according to approved procedures.
• Participate in analytical method transfer/ validation/ verification, new product introduction and equipment qualification.
• Assist in conducting laboratory investigations and ensure effective implementation of related actions within the agreed timeframe.
• Provide inputs for the development and revision of Analytical Standards, Standard Operating Procedures, Work Instructions and other GMP documents.
• Maintain proper laboratory housekeeping, laboratory inventory and ensure inspection readiness.
• Execute quality and laboratory improvement initiatives and other special projects.
• Perform equipment preventive maintenance and calibration.
• Perform review of laboratory documents such as orphan data check and equipment logs.
• Perform other duties as assigned by their direct manager.