QA Specialist II - Supplier Quality

Summary of Objective

This position is part of PCI's Quality Compliance team responsible for the quality aspects of supplier quality management for suppliers that provide raw materials, components, contract test labs and services for GMP operations. The position is responsible for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.

Essential Duties and Responsibilities

• Responsible for compliance relative to the overall Supplier Qualification Program by scheduling and conducting supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports.
• Responsible for follow up and tracking of supplier audit observations to ensure timely closure.
• Monitor, communicate, and reconcile supplier change notifications, supplier non-conformances, and complaints.
• Responsible for reviewing all audit responses to assure non-recurrence of deficiencies.
• Drafting, review, and management of supplier quality assurance agreements and non-disclosure agreements.
• Collaborate with Corporate Supplier Quality team members; align on Supplier Qualification program initiatives, report status of site-specific Supplier Qualification actions.
• Support Supplier Risk Assessments.
• Support Annual Product Quality Review's.
• Support Quality System Events impacting the Supplier Quality program.
• Request, reconcile, and file Supplier Qualification documentation from vendors.
• Track and maintain KPI metrics for the Supplier Qualification program.
• Writes and revises Standard Operating Procedures (SOP).
• Support continuous improvement initiatives.
• Ability to travel 10-20%
• Performs other duties as assigned.

Special Demands

• Is assigned tasks and duties regularly from direct manager and senior team members.
• Ability to work independently with moderate support from direct manager.
• Ability to maintain organization of assigned tasks and meet deadlines.
• Ability to think strategically and tactically.
• Frequent reading, writing, and verbal communication.
• Able to work in a highly complex and regulated environment.
• Able to translate ideas to actual concepts and processes.

Work Environment

• Interacts with all departmental staff, external clients and suppliers.
• TRAVEL – 10-20%

Qualifications

• Bachelor of Science Degree preferred with 5+ years' in a QA GMP environment; High School diploma with 10+ years' of progressive experience in QA GMP environment considered.
• Ability to articulate and comprehend industry related technical subject matter.
• Exceptional organizational skills.
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Ability to work in a dynamic, fast-paced environment.
• Proficiency in MS Office including Word, Excel, Access and Visio.
• Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is preferred.
• Knowledge of regulatory guidance (i.e., FDA 21CFR Part 210, 211 & 820; EMA), and ICH is preferred.
• Experience working with cross-functional teams.
• Detail oriented and a results-driven team player.
• Honesty, integrity, respect and courtesy with all colleagues.