Category: Scientific & Clinical
Title: Quality Specialist - II
Location: West Point, PA
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- Initiates audit requests in the third party auditing vendor’s system.
- Obtains relevant background information from sites and data systems to complete the Pre-audit questionnaire (supplier contact information, materials to be audited, auditing standard to apply), resolves any date discrepancies with sites and submits to vendor.
- Follows up with third party auditing vendor to provide responses to supplier questions.
- Monitors and tracks audit scheduling and completion.
- Enters audit reports and supporting information into the auditing Trackwise application
- Supports Business Process System activities as assigned by the Director, Global Auditing
- A minimum of a Bachelor’s Degree in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent) with 5-8 years of manufacturing, technology, and/or quality operation experience within an EU/FDA, API, Drug Product, Medical Device or equivalent environment.
- Prior experience as part of cross functional teams.
- Ability to work independently with limited supervision.
- Excellent/accomplished communication (oral and written), negotiation, and facilitation skills.
- Organizational and time management skills and demonstrated ability to independently manage multiple priorities, deal with ambiguity, changing priorities, and ensure timely completion of deliverables.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.