QA Specialist II - Supplier Quality

PCI Pharma Services; Bedford (NH); On-site; USD 85,000 - 105,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a Supplier Quality professional to oversee the Supplier Qualification program across PCI facilities. You will schedule and perform audits, manage observations, and ensure quality and regulatory compliance in GMP operations.

Role requires collaboration with the Corporate Supplier Quality team and travel up to 20%. The ideal candidate holds a Science degree with QA GMP experience or substantial related expertise, with strong documentation and

Qualifications

• Bachelor of Science with 5+ years QA GMP experience; or HS diploma with 10+ years in QA GMP.
• Excellent organizational and communication skills.
• Ability to work in fast-paced regulated environment.
• Knowledge of FDA EMA ICH guidelines preferred.

Responsibilities

• Schedule and conduct supplier audits to evaluate SOP and regulatory compliance.
• Track audit observations and ensure timely closure.
• Manage supplier change notifications and non-conformances.
• Draft supplier QA agreements and NDAs.
• Collaborate with Corporate Supplier Quality on initiatives.
• Support supplier risk assessments and Annual Product Quality Review.
• Travel 10–20%.
• Maintain KPI metrics for Supplier Qualification.

Skills

Auditing

QA GMP

Regulatory knowledge

Documentation

Cross-functional teamwork

MS Office

Education

Bachelor of Science

High School diploma with 10+ years QA GMP

Tools

MS Office

Visio

Access

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.