INCOG BioPharma Services · 2 months ago
QA Specialist, Supplier Quality
Fishers, IN
Full-time
Onsite
Mid, Senior Level
5+ years expINCOG BioPharma Services is a world-class CDMO focused on parenteral injectable drugs. The QA Specialist - Supplier Quality will be responsible for maintaining supplier quality through qualification, oversight activities, and compliance with FDA regulations, while collaborating with cross-functional teams and suppliers in the pharmaceutical industry.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
Lead the qualification and approval process for new suppliers, including evaluation of supplier quality systems, capabilities, and compliance with GMP requirements
Maintain and manage supplier qualification files, approved supplier lists, and related documentation in accordance with regulatory requirements and company procedures
Collaborate with Purchasing to ensure that only approved materials are procured from qualified and approved vendors
Review and process Supplier Change Notifications (SCNs), assessing potential impact to product quality and coordinating cross-functional review and approval
Investigate and manage supplier complaints
Coordinate with external audit service providers to perform supplier audits
Support supplier quality agreements, technical agreements, and quality documentation as needed
Participate in cross-functional teams for new product introductions, process improvements, and quality initiatives
Qualification
Required
Bachelor's degree OR 5+ years of experience in supplier quality management within a pharmaceutical, biopharmaceutical, or medical device GMP environment
Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing
Excellent written and verbal communication skills with the ability to interact effectively with internal stakeholders and external suppliers
Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment
Detail-oriented with strong analytical and problem-solving abilities
Ability to work both independently and collaboratively in a team environment
Preferred
Experience with supplier auditing or audit coordination
Knowledge of FDA 21 CFR Part 211 and ICH Q7
Familiarity with quality management systems (QMS) and document management systems
ASQ Certified Quality Auditor (CQA) or similar quality certification
Experience with risk assessment methodologies and tools
Previous experience working with contract manufacturers or in a CDMO environment
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
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