Senior QA Specialist, Supplier Quality

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.

Essential Job Functions:

·       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

Special Job Requirements:

·       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

Additional Preferences:

·       Knowledge of FDA 21 CFR Part 211 and ICH Q7

·       ASQ Certified Quality Auditor (CQA) or similar quality certification

·       Previous experience working with contract manufacturers or in a CDMO environment

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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