QA Specialist II - Supplier Quality

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

PCI Pharma Services in New Hampshire seeks a QA professional to oversee supplier qualification for GMP operations. You will audit suppliers, track audit findings, and manage change notifications and non-conformances to ensure continuous quality.

The role supports KPI metrics, SOP development, and risk assessments, with 10–20% travel. A BS in science with 5+ years in QA GMP or a HS diploma with 10+ years is required.

Qualifications

• Bachelor of Science preferred with 5+ years in a QA GMP environment.
• High School diploma with 10+ years of QA GMP experience considered.
• Ability to articulate and comprehend industry related technical subject matter.
• Excellent organizational and written communication skills.

Responsibilities

• Audit suppliers for compliance with SOPs, quality and regulatory standards.
• Track supplier audit observations and ensure timely closure.
• Manage supplier change notifications, non-conformances, and complaints.
• Draft and manage supplier QA agreements and NDAs.
• Collaborate with Corporate Supplier Quality to align initiatives.

Skills

GMP QA experience

MS Office

Regulatory knowledge

Cross-functional teamwork

Communication skills

Education

Bachelor of Science

High School diploma

Tools

MS Office

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective

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 for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.

Essential Duties and Responsibilities

• Responsible for compliance relative to the overall Supplier Qualification Program by scheduling and conducting 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 ensure timely closure.
• Monitor, communicate, and reconcile supplier change notifications, supplier non-conformances, and complaints.
• Responsible for reviewing all audit responses to assure non-recurrence of deficiencies.
• Drafting, review, and management of supplier quality assurance agreements 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 from vendors.
• Track and maintain KPI metrics for the Supplier Qualification program.
• Writes and revises Standard Operating Procedures (SOP).
• Support continuous improvement initiatives.
• Ability to travel 10-20%.
• Performs other duties as assigned.

Special Demands

• Is assigned tasks and duties regularly from direct manager and senior team members.
• Ability to work independently with moderate support from direct manager.
• 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.

Work Environment

Interacts with all departmental staff, external clients and suppliers. TRAVEL – 10-20%

Qualifications

• Bachelor of Science Degree preferred with 5+ years’ in a QA GMP environment; High School diploma with 10+ 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.
• Ability to work in a dynamic, fast-paced environment.
• Proficiency in MS Office including Word, Excel, Access and Visio.
• Experience with GMP quality systems in a pharmaceutical/biotech/ medical device environment is preferred.
• Knowledge of 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.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) 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. 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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.