What are the responsibilities and job description for the Audit Specialist position at Lead Candidate?
Audit Specialist
WHO?
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.
WHAT?
- 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
YOU!
- 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
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
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.