Title: Quality Specialist - III (Senior)
Location: West Point, PA
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- Managing workflows, data, forms, reports, templates, in SAP and other GMP systems
- Should be capable of developing and providing innovative solutions for delivering optimal end user experience
- Monitor for due dates; follow up with stakeholders for updates and escalate issues and overdue items
- Collaborate with team/cross functional departments for development of the site, ensure compliance and resolve discrepancies
- Perform other support activities as requested, e.g. data entry into SAP, Trackwise, etc.
- Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations.
- Coordinate and/or support the preparation of procedures, processes and quality improvements.
- Assists in the coordination of significant quality events including fact finding, investigation support, coordination of clinical quarantine and recovery actions.
- Collaboration across IPT functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.
- Actively using and championing the use of Lean Six Sigma (LSS) and tools, both in problem solving and day-to-day operational activities.
- Perform other support activities as requested, e.g. data entry into SAP and Trackwise based systems.
- Bachelors/Master’s Degree in Sciences or equivalent with minimum of 4 year experience in cGMP regulated environment
- Familiarity with batch disposition (release) activities
- Prior experience assessing or reviewing investigations, deviation management support, and Corrective/Preventative Actions (CAPAs) is a plus
- Previous experience in quality control, quality assurance, auditing or regulatory affairs.
- Ability to independently manage multiple priorities and projects.
- Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
- Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management.
- Computer skills; knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.
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.
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