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Job description
Senior QA Specialist, Supplier Quality
WHO?
Join our dynamic Quality Assurance team as a QA Senior Specialist - Supplier Quality, where you'll play a critical role in maintaining the integrity of our supply chain and protecting product quality. This position offers the opportunity to work cross-functionally with Purchasing, Quality Operations, and external audit partners while building strong relationships with suppliers across the pharmaceutical industry. You'll be part of a collaborative team that values innovation, problem-solving, and continuous improvement in a fast-paced GMP environment.
As the QA Senior Specialist - Supplier Quality, you will serve as the primary point of contact for supplier qualification and oversight activities. You will be responsible for qualifying new suppliers, managing supplier qualification documentation, processing supplier change notifications, and handling supplier complaints. This role requires strong attention to detail, excellent communication skills, and the ability to balance multiple priorities while ensuring compliance with FDA regulations and INCOG's quality standards.
WHAT?
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
Write and revise SOPs and other documents governing the Supplier QA system
Review and process Supplier Change Notifications (SCNs), assessing potential impact to product quality and coordinating cross-functional review and approval
Perform risk-based evaluation of suppliers and supplier issues
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
Perform Supplier QA metric reporting
YOU
Bachelor's degree and 3 years experience OR 10+ years of experience in supplier quality management within a pharmaceutical, biopharmaceutical, or medical device GMP environment
Experience with supplier auditing or audit coordination
Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing
Familiarity with quality management systems (QMS) and document management systems
Experience with risk assessment methodologies and tools
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
Why INCOG?
Paid vacation days, amount based on tenure, and paid sick time
PTO (based on tenure) & 11 holidays (9 observed + 2 floating)
401(k) plan with company match up to 3.5% of salary, vested immediately
Choice of health & wellness plans
FSA and HSA programs
Dental & vision care
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
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Worksite address
fishers, IN, 46085, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.