QA Specialist I - Supplier Quality

Job Overview

PCI Pharma Services (PCI) is seeking a Quality Compliance professional to manage the Supplier Qualification program across all PCI facilities. The role focuses on ensuring all aspects of supplier quality management for raw materials, components, contract test labs, and services are compliant with GMP operations.

• 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 and align on Supplier Qualification program initiatives. Report status of site‑specific Supplier Qualification actions.
• Support Supplier Risk Assessments and Annual Product Quality Reviews.
• Support Quality System events impacting the Supplier Quality program.
• Request, reconcile, and file Supplier Qualification documentation.
• Provide support for Quality Council meetings.
• Write and revise Standard Operating Procedures (SOP).
• Support continuous improvement initiatives.
• Perform other duties as assigned.

Assign tasks and duties regularly from direct manager and senior team members. Maintain organization of assigned tasks, meet deadlines, think strategically and tactically, and communicate frequently in writing, speaking, and reading. Work in a highly complex and regulated environment and translate ideas into concrete concepts and processes.

Interact with all departmental staff, external clients, and suppliers. Travel: less than 10% local.

Bachelor of Science preferred with 3+ years in a QA GMP environment;
High School diploma with 5+ years of progressive experience considered. Ability to articulate and comprehend industry‑related technical subject matter. Exceptional organizational and interpersonal skills. Proficiency in MS Office (Word, Excel).

Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment preferred. Familiarity with regulatory guidance (FDA 21

CFR Part 210, 211 & 820; EMA, ICH) preferred. Experience working with cross‑functional teams. Detail oriented and results‑driven team player.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose:
Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.