Quality Assurance Specialist II, CDMO
SGS North America Inc.

Job Info

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Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Job Description

• Support quality teams when required
• Assist in Quality improvement projects
• Provide support during customer and regulatory audits - where required
• Deviation / investigation / customer complaint closure. Provide guidance on deviation/investigation content and help identify CAPA's. Report major/critical findings to the Senior Manager, Quality Assurance
• Provide quality guidance to ensure change controls are justified and actions are taken to reduce the impact
• Review quality documentation and any associated validation protocols or reports to achieve project timelines
• Support facilities management to ensure calibration and maintenance procedures are suitably defined and performed
• Support production and technical team in the introduction of new equipment and processes
• Assess and approve feasibility/technical reports ready for scale-up to GMP batches
• Define and report appropriate metrics to discuss during Quality review meetings

Qualifications

• Bachelor's degree in Chemistry, Biology, or a science-related field
• 3+ years of experience in a regulated manufacturing environment
• Knowledge of scientific principles and Good Manufacturing Practice (GMP)

This job has expired.