Quality Specialist - II

Our Quality Assurance 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.

Responsibilities:

• Support for the Global Enterprise Asset Management System (EAMS) Project, including:
• Migration of data from legacy data to new system
• Support of required project documentation
• Support the Quality IPT with other activities including:
• Batch record documentation and/or audit
• CoA/CoC generation and review
• Data review and updates
• Additional responsibilities may be assigned as needed
• Attends team meetings and any required cross-functional meeting to ensure alignment of priorities and escalation of obstacles

Education Minimum Requirement:

• Bachelor's degree (BA or BS) is preferred.
• Candidates with an Associate's degree will be considered if they have relevant experience.

Required Experience and Skills:

• 3–5 years of relevant experience within quality assurance, quality control, or investigation.
• At least two (2) years of experience in a GMP pharmaceutical manufacturing facility.
• Direct involvement in activities such as batch record and documentation reviews, investigations, corrective actions, complaints, and quality system management.
• Experience in Quality Assurance.
• Experience working in a pharmaceutical packaging facility.
• Experience with SAP, maintenance systems, and/or SOPs.