Quality Systems Specialist

Quality Systems Specialist
Location: Exton, PA - Hybrid Onsite for 2days- But Need candidate within Commutable distance ONLY Local. 
Duration: 12 Months+ 
Shift: 1Shift

CANDIDATES MUST BE LOCAL TO EXTON
2 days a week onsite - Tuesdays & Thursdays

HM Top Skills:
Bachelor’s degree
Prior cGMP experience is a must have
Ideal candidate will have 3-5 years' experience
Must have QUALITY experience (Quality System or Quality Assurance)

Skills Needed: Auditing, Review Protocols, SOP and protocol writing, metrics monitoring, Document control processes: electronic quality systems
Quality Skills: Inspections, Compliance 
Software: learning management systems (LMS)/ training operations

MUST HAVE SKILLS: 
Prior cGMP experience is a must have
Ideal candidate will have 3-5 years' experience
Must have QUALITY experience

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.

Qualifications
• 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 *** 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.

Functional Skills
• 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.