drjobs Quality Systems Specialist

Quality Systems Specialist

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1 Vacancy
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Job Location drjobs

Exton, PA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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.
Requirements:
  • Bachelors 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.

Employment Type

Full-time

Company Industry

About Company

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