Sr. QA Specialist - Supplier Quality

Position Title

Sr. QA Specialist - Supplier Quality

Bedford, New Hampshire

Quality Assurance

QA Dir, Quality Systems & Compliance

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

• Perform supplier audits to evaluate compliance to SOPs, quality and regulatory standards and create and issue audit reports.
• Follow up and track audit observations to assure timely closure.
• Monitor and communicate supplier change notifications and manage supplier non‑conformance and complaint handling.
• Review audit responses to assure non‑recurrence of deficiencies.
• Maintain, trend, analyze and report quality metrics related to supplier audits and performance.
• Draft, review and manage supplier quality assurance agreements (QAA’s) and non‑disclosure agreements.
• Provide support for Quality Council meetings.
• Assist during FDA and other regulatory agency inspections.
• Complete assignments and work independently without appreciable direction.
• Write and revise QA Standard Operating Procedures (SOP).
• Support continuous improvement initiatives.
• Perform other duties as assigned.

• Bachelor of Science degree preferred with 15+ years in a QA GMP environment; alternatively, Master’s degree with 10+ years; or High School diploma with 20+ years of progressive experience.
• Exceptional organizational skills.
• Excellent interpersonal, verbal and written communication skills.
• Proficiency in MS Office (Word, Excel, Access, Visio).
• Experience with GMP quality systems in a pharmaceutical, biotech or medical device environment.
• Thorough knowledge of FDA regulations (21
  
  CFR Part 210, 211 & 820), Guidance, ICH and EMEA and other agency regulations.

• Auditing certification (ASQ, CQA or similar).
• Experience working with cross‑functional teams and giving training or presentations to large groups.
• Detail oriented and results‑driven team player.
• Ability to work in a dynamic, fast‑paced environment.
• Honesty, integrity, respect and courtesy with colleagues.
• Creative with ability to work independently while balancing independent thinking.
• Resilient through operational and organizational change.

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.