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PCI Pharma Services

QA Specialist I - Supplier Quality

PCI Pharma Services · Bedford, New Hampshire, United States

Pharmaceutical Manufacturing · 5,001-10,000 employees

20 h ago
Mid (2-5 yrs) Full-time United States
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About the role

Responsible for managing supplier quality aspects, including tracking audit observations, managing non-conformances, and drafting quality assurance agreements. The role ensures the successful execution of the Supplier Qualification program across all PCI facilities.

What they look for

Supplier Quality Management GMP Compliance Audit Tracking Quality Assurance Agreements Supplier Risk Assessment SOP Writing Non-conformance Handling Complaint Handling MS Office Regulatory Guidance Cross-functional Collaboration Technical Communication

Requirements

Requires a Bachelor's degree with 3+ years of QA GMP experience, or a high school diploma with 5+ years of progressive experience. Proficiency in MS Office and familiarity with FDA, EMA, and ICH regulatory guidance is preferred.

Full 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.

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 follow up and tracking of supplier audit observations to ensure 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.
  • Drafting, review and management of supplier quality assurance agreements (QAA’s) 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.
  • Provide support for Quality Council meetings.
  • Writes and revises Standard Operating Procedures (SOP).
  • Support continuous improvement initiatives.
  • Performs other duties as assigned.

Special Demands:

  • Is assigned tasks and duties regularly from direct manager and senior team members.
  • 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% local

Qualifications:

  • Bachelor of Science Degree preferred with 3+ years’ in a QA GMP environment; High School diploma with 5+ 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.
  • Proficiency in MS Office including Word, Excel.
  • Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is preferred.
  • Familiarity with 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.