QA Specialist I - Supplier Quality

Essential Duties And Responsibilities

• Follow up and track supplier audit observations to ensure timely closure.
• Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling.
• Review all audit responses to assure non-recurrence of deficiencies.
• Draft, review and manage supplier quality assurance agreements (QAA’s) 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.
• Provide support for Quality Council meetings.
• Writes and revises Standard Operating Procedures (SOP).
• Support continuous improvement initiatives.

Special Demands

• Assigned tasks and duties regularly from direct manager and senior team members.
• 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.

Qualifications

• Bachelor of Science Degree preferred with 3+ years’ in a QA GMP environment; High School diploma with 5+ 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.
• Proficiency in MS Office including Word, Excel.
• Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is preferred.
• Familiarity with 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.