What are the responsibilities and job description for the Quality Systems Specialist position at Katalyst CRO?
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.
- Bachelor's degree, preferably in chemistry, biochemistry, or equivalent technical discipline with 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.
- Ideal candidate will have 3-5 years' experience.
- Must have Quality experience.
- Works as a collaborative player and effectively seeks/ conveys understanding of diverse viewpoints.
- Communicates with colleagues across levels as needed and influences for the best outcomes.
- Presents information (written and verbal) in a clear, well thought out way and tailored to the audience.
- Escalates issues/problems and seeks support in a timely manner.
