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.
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