Sr. QA Specialist - Supplier Quality

PCI Pharma Services; Bedford (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

JobRx, Inc. is seeking a Sr. QA Specialist in Bedford, New Hampshire, to manage supplier quality, ensuring compliance with quality standards. This role involves performing audits, drafting quality agreements, and assisting during regulatory inspections.

Candidates should have 15+ years in a QA GMP environment, excellent communication skills, and knowledge of FDA regulations. The position offers an opportunity to work in a dynamic environment with a focus on continuous improvement.

Qualifications

• 15+ years in a QA GMP environment; alternatively, 10+ years with a Master’s degree; or 20+ years with a High School diploma.
• Experience with GMP quality systems in pharmaceutical, biotech, or medical device environments.
• Thorough knowledge of FDA regulations (21CFR Part 210, 211 & 820) and other relevant regulations.

Responsibilities

• Perform supplier audits to evaluate compliance with quality standards.
• Draft, review, and manage supplier quality assurance agreements.
• Assist during FDA and other regulatory agency inspections.

Skills

Exceptional organizational skills

Excellent interpersonal and communication skills

Proficiency in MS Office (Word, Excel, Access, Visio)

Detail oriented and results-driven

Education

Bachelor of Science degree or equivalent experience

Job description

Position Title

Sr. QA Specialist - Supplier Quality

Location

Bedford, New Hampshire

Department

Quality Assurance

Reporting To

QA Dir, Quality Systems & Compliance

Overview

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.

Responsibilities

• 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.

Required Qualifications

• 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 (21CFR Part 210, 211 & 820), Guidance, ICH and EMEA and other agency regulations.

Preferred Qualifications

• 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.

Equal Employment Opportunity Statement

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.