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Are you passionate about quality and compliance in the pharmaceutical industry? INCOG’s Quality Assurance team is looking for an Audit Specialist to play a key role in ensuring our audit program runs smoothly and effectively. You will join a collaborative, fast-paced team that values attention to detail, open communication, and a commitment to continuous improvement. This is an exciting opportunity to work at the center of our quality operations, partnering across departments and directly supporting the integrity of our GMP-regulated manufacturing environment.

The Audit Specialist is responsible for supporting and providing quality oversight of client and regulatory audit activities, with specific responsibilities associated with facilitating audits and supporting audit demands. This position collaborates with internal stakeholders to obtain supporting documentation, reviews audit observations, and compiles audit responses ensuring appropriate corrective and preventive actions are in place. The Audit Specialist serves as a key liaison between INCOG and external auditors, ensuring a professional, organized, and compliant audit experience.

Essential Job Functions:

·       Coordinate and facilitate client, regulatory, and corporate audit activities, including scheduling, logistics, and preparation of audit rooms and materials

·       Serve as a primary point of contact for external auditors during on-site visits, ensuring a professional and organized audit experience

·       Collaborate with internal stakeholders across Quality, Manufacturing, Technical Services, Engineering, and Supply Chain to gather and compile supporting documentation in response to audit requests

·       Review audit observations, findings, and regulatory citations; assist in drafting clear, accurate, and timely audit responses

·       Track and manage audit commitments, ensuring corrective and preventive actions (CAPAs) are appropriately assigned, documented, and completed on schedule

·       Maintain the audit schedule and audit tracking systems, ensuring all audit-related records are current and inspection-ready

·       Assist in the preparation of front room and back room teams for regulatory inspections, including coordination of subject matter experts (SMEs) and document readiness

·       Support internal audit program activities, including scheduling, documentation, and follow-up on observations

·       Compile and organize audit metrics, trend data, and summary reports for management review

·       Ensure audit-related documentation is maintained in accordance with INCOG’s Quality Management System (QMS) and applicable regulatory requirements

·       Participate in continuous improvement initiatives related to the audit program and inspection readiness

·       Support the development and revision of SOPs, work instructions, and templates associated with audit and inspection management processes

Special Job Requirements:

·       Bachelor’s degree in Life Sciences or a related field (equivalent work experience may be considered)

·       2-4 years of experience in a GMP-regulated pharmaceutical, biopharmaceutical, or CDMO environment

·       Demonstrated experience supporting or coordinating client, regulatory, or internal quality audits

·       Effective oral and written communication skills with the ability to articulate audit findings, observations, and responses clearly and professionally

·       Strong organizational skills with the ability to manage multiple audit activities and deadlines simultaneously

·       High attention to detail with the ability to review and compile complex documentation accurately

·       Ability to remain calm, professional, and composed in fast-paced, high-pressure audit situations

·       Knowledge and experience in auditing and applying knowledge of company and customer processes

·       Proficiency with Quality Management Systems (QMS) and document management systems

Additional Preferences:

·       Knowledge of US and international regulations, guidelines, and other compendia (e.g., FDA, EMA, ICH, PIC/S)

·       Quality auditing certification (e.g., ASQ Certified Quality Auditor (CQA) or equivalent) is a plus

·       Experience with sterile injectable drug product manufacturing or parenteral dosage forms

·       Familiarity with regulatory inspection processes from agencies such as FDA, EMA, or Health Canada

·       Experience with electronic QMS platforms (e.g., Veeva, TrackWise, MasterControl)

·       Experience with combination products and knowledge of ISO 13485.

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.

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