Job Description
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 the mission of serving patients.
Key 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.
Basic Qualifications
- 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.
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
Company Description
The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.