Quality Systems Specialist
Job Responsibilities:
- Perform core quality systems activities including SOP revisions and inspection readiness support
- Develop, improve, and maintain regional Quality System SOPs
- Analyze, track, and report quality and risk metrics and drive corrective actions
- Identify gaps within quality systems and escalate issues appropriately
- Support project management initiatives within the quality systems function
- Collaborate with cross-functional teams to ensure quality compliance and outcomes
Skills:
- Strong knowledge of cGMP regulations and quality systems
- Experience with SOP writing, document control, and quality metrics
- Hands-on experience with electronic quality systems (eQMS)
- Strong communication and stakeholder management skills
- Ability to identify risks, escalate issues, and drive resolution
Education/Experience:
- Bachelor’s degree in Chemistry, Biochemistry, or equivalent technical discipline
- 3–5 years of experience in Quality Systems within a regulated (cGMP) environment
- Experience supporting audits, regulatory inspections, training systems, or document control
- Proven performance in prior quality or compliance roles
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