Specialist Quality Assurance

Job Description: • The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic, results-oriented, and experienced Quality Assurance Specialist to join our organization as a Remote Worker. • The candidate will be responsible for supporting the global Manufacturing Execution System (MES) projects and initiatives to ensure compliance, quality assurance, and operational excellence in a GMP-regulated environment. • This is an excellent opportunity for a highly experienced and talented individual to contribute to mission of serving patients. Responsibilities: • Ensure quality oversight and compliance for MES and PT project activities. • Support validation and qualification efforts for computerized systems in alignment with GMP requirements. • Review and approve documentation related to MES workflows, change controls, and deviations. • Collaborate with cross-functional teams to ensure quality standards are met during system implementation. • Participate in risk assessments and support mitigation strategies for quality-related issues. • Ensure that quality processes and procedures are updated and aligned with project deliverables. • Provide training and guidance on quality practices and regulatory compliance. • Support audits and inspections by providing documentation and subject matter expertise. • Monitor and report on quality metrics and continuous improvement initiatives. • Ensure alignment with global quality standards and local regulatory requirements. Requirements: • Bachelor's or master's degree in Life Sciences, Engineering, or related field. • Proven experience in quality assurance within a GMP-regulated manufacturing environment. • Experience supporting MES and process transformation initiatives. • Strong understanding of validation principles and regulatory compliance. • Excellent documentation and communication skills. • Ability to work collaboratively in cross-functional teams. • Detail-oriented with strong analytical and problem-solving skills. • At least 5 years of experience in quality assurance or related roles. Apply tot his job