Sr. QA Specialist - Supplier Quality

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 to ensure all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.

Responsibilities

Responsible for compliance relative to the overall Supplier Qualification Program by performing 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 assure timely closure; Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling; Responsible for reviewing all audit responses to assure non-recurrence of deficiencies; Maintain, trend, analyze and report quality metrics as it relates to supplier audits and performance; Drafting, review and management of supplier quality assurance agreements (QAA’s) and non-disclosure agreements; Provide support for Quality Council meetings; Provides support during FDA and other regulatory agency inspections; Complete assignments and works independently without appreciable direction; Writes and revises QA Standard Operating Procedures (SOP); Support continuous improvement initiatives; Performs other duties as assigned

Requirements

Bachelor of Science Degree preferred with 15+ years’ in a QA GMP environment; alternatively, Master’s Degree with 10+ years’ experience in a QA GMP environment. (High School diploma with 20+ years’ of progressive experience in QA GMP environment).; Exceptional organizational skills; Excellent interpersonal skills and the ability to communicate well orally and in writing; Proficiency in MS Office including Word, Excel, Access and Visio; Excellent verbal and written communication skills required; Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is a must; Thorough knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) Guidance’s, and ICH is required; EMEA and other agency regulations

Nice to have

Auditing certification preferred (i.e., ASQ, CQA or similar); Experience working with cross-functional teams, including giving training and/or presentations to large groups; Detail oriented and a results driven team player; Ability to work in a dynamic, fast paced work environment; Honesty, integrity, respect and courtesy with all colleagues; Creative with the ability to work with minimal supervision and balanced with independent thinking; Resilient through operational and organizational change