Quality Compliance Auditor – GMP, Independent

Exela Pharma Sciences, LLC; Lenoir, Northern (NC, KY); Hybrid; USD 60,000 - 85,000; Full time

Job summary

Exela Pharma Sciences, LLC is seeking a Quality Administrator to independently monitor compliance with CGMP and procedures. You will report to the CQO and CEO, ensuring accurate, timely quality reporting and objective assessments. Comprehensive on-the-job training will be provided.

The role involves working closely with Operations and Quality teams while maintaining independence and discretion in reporting and documentation.

Qualifications

• Experience in a disciplined, procedure-driven environment.
• Ability to follow rules, procedures, instructions, and controls precisely.
• Strong written and oral communication skills for factual reporting.
• Ability to absorb new subject matter quickly and apply critical thinking.

Responsibilities

• Independently verify personnel follow documented procedures and instructions exactly.
• Perform tasks per work instructions tailored to each Administrator position.
• Conduct structured reviews and follow-up on task deadlines, completion, and thoroughness.
• Compare actual practices with procedures; document gaps or discrepancies.
• Initiate a formal Quality Event and CAPA in the QMS when findings meet criteria.
• Track recurring or systemic noncompliance patterns and escalate to leadership.
• Prepare clear reports on task status and findings for CQO/CEO weekly or as needed.
• Confirm follow-up actions are completed and integrated into practice.
• Maintain independence and report concerns without bias.

Skills

Attention to detail

Strong communication

Independent worker

Critical thinking

Documentation

Education

Bachelor’s degree in a related field

Job description

Exela Pharma Sciences, LLC is seeking a Quality Administrator to independently monitor compliance with CGMP and procedures. You will report to the CQO and CEO, ensuring accurate, timely quality reporting and objective assessments. Comprehensive on-the-job training will be provided.

The role involves working closely with Operations and Quality teams while maintaining independence and discretion in reporting and documentation.