PCI Pharma Services

QA Specialist I - Supplier Quality

Bedford, NH, USA

Sponsorship not specifiedDetected 7 days ago

ComplianceGMPFDA RegulatoryMedical DevicesMicrosoft Office

About the role

Bridge to thousands of biopharma companies and their patients.
The position is responsible for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.
Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling.
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 Quality System events impacting the Supplier Quality program.
Provide support for Quality Council meetings.
Support continuous improvement initiatives.
Performs other duties as assigned.
Ability to maintain organization of assigned tasks and meet deadlines.

Ability to articulate and comprehend industry related technical subject matter.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Proficiency in MS Office including Word, Excel.
Experience working with cross-functional teams.
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.
Exceptional organizational skills.
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.
Detail oriented and a results-driven team player.
Honesty, integrity, respect and courtesy with all colleagues.

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.
Familiarity with regulatory guidance (i.e., FDA 21CFR Part 210, 211 & 820
EMA), and ICH is preferred.

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.

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.

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 o

This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.