Audit Specialist

INCOG BioPharma Services•Fishers, IN

4d•Onsite

About The Position

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.

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

Nice To Haves

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.

Responsibilities

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