Quality Systems Specialist

SGS_JOB_2265

Business Support
 Pennsylvania
Electronic Quality Systems
cGMP
Auditing
SOP & Protocol Writing
Regulatory Inspections
Document Control Processes
Technical Writing

Contract - 12 Months+

Location: Exton PA USA 19341 (Hybrid) Candidates Must Be Local to Exton 3x a week (Monday, Tuesday, Thursday for the Exton site) • Prior cGMP experience is a must have • Ideal candidate will have 3-5 years' experience • Must have Quality experience

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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