Quality Systems Specialist
Job Responsibilities:
- Perform core regional quality systems activities as assigned (e.g., revising procedures; assisting in inspection readiness) following defined procedures.
- Develop, improve, and revise regional quality system SOPs.
- Conduct ongoing analysis and reporting of key quality and risk metrics and required actions.
- Monitor and identify gaps within quality systems area and escalate for appropriate action.
- Support project management for programs/ projects within quality systems area, and communicate with cross-functional teams within site/ area to drive quality outcomes.
Skills:
- 3+ years of experience relevant to role (e.g. auditing and regulatory inspections; learning management systems/ training operations; document control processes; electronic quality systems).
- Experience in compliance with cGMPs and relevant health authority and client regional guidelines.
- Experience in execution of quality processes within own quality systems area (e.g., SOP and protocol writing, metrics monitoring), and assisting in resolution of issues .
- Proven performance in earlier role.
Education/Experience:
- Bachelor’s degree, preferably in chemistry, biochemistry, or equivalent technical discipline
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