Senior QA Specialist, Supplier Quality

Lead Candidate; Fishers (IN); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Paid vacation days

PTO & holidays

401(k) match

Health plans

FSA/HSA

Job summary

Lead Candidate in Fishers, IN, is seeking a QA Senior Specialist - Supplier Quality to manage supplier qualification, documentation, and change notifications within a GMP environment. The role involves cross-functional coordination with Purchasing and external audit partners to ensure product quality across the pharmaceutical supply chain.

The ideal candidate will have strong GMP knowledge, supplier auditing experience, and excellent communication skills to drive risk-based evaluations and

Qualifications

• Bachelor's degree or higher in a relevant field.
• Experience with GMP and supplier quality management.
• Strong communication with internal/external stakeholders.
• Experience with supplier auditing or audit coordination.
• Experience with risk assessment methodologies.

Responsibilities

• Lead the qualification and approval process for new suppliers, evaluating quality systems and GMP compliance.
• Maintain supplier qualification files, approved supplier lists, and documentation.
• Collaborate with Purchasing to ensure only approved materials from qualified vendors.
• Write and revise SOPs governing the Supplier QA system.
• Review and process Supplier Change Notifications and coordinate cross-functional reviews.
• Perform risk-based evaluation of suppliers and supplier issues.
• Investigate and manage supplier complaints.
• Coordinate supplier audits with external providers.
• Support supplier quality agreements and quality documentation.
• Participate in cross-functional teams for new product introductions and quality initiatives.

Skills

Quality management

GMP knowledge

Supplier quality

Auditing

Education

Bachelor's degree

Tools

QMS software

Document management systems

Job description

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

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

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.