Sr. QA Specialist - Supplier Quality

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Position Title : Sr. QA Specialist – Supplier Quality

Location: Bedford, New Hampshire

Department: Quality Assurance

Reporting To: QA Dir, Quality Systems & Compliance

Responsible For (Staff): No

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 to ensure 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 performing 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 assure 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

Maintain, trend, analyze and report quality metrics as it relates to supplier audits and performance

Drafting, review and management of supplier quality assurance agreements (QAA’s) and non-disclosure agreements

Provide support for Quality Council meetings

Provides support during FDA and other regulatory agency inspections

Complete assignments and works independently without appreciable direction

Writes and revises QA Standard Operating Procedures (SOP)

Support continuous improvement initiatives

Performs other duties as assigned.

QUALIFICATIONS:

Required:

Bachelor of Science Degree preferred with 15+ years’ in a QA GMP environment; alternatively, Master’s Degree with 10+ years’ experience in a QA GMP environment. (High School diploma with 20+ years’ of progressive experience in QA GMP environment).

Exceptional organizational skills

Excellent interpersonal skills and the ability to communicate well orally and in writing

Proficiency in MS Office including Word, Excel, Access and Visio

Excellent verbal and written communication skills required

Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is a must

Thorough knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) Guidance’s, and ICH is required; EMEA and other agency regulations

Preferred:

Auditing certification preferred (i.e., ASQ, CQA or similar)

Experience working with cross-functional teams, including giving training and/or presentations to large groups

Detail oriented and a results driven team player

Ability to work in a dynamic, fast paced work environment

Honesty, integrity, respect and courtesy with all colleagues

Creative with the ability to work with minimal supervision and balanced with independent thinking

Resilient through operational and organizational change

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• 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.