Quality Administrator

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Administrator

Position Summary

The Quality Administrator independently monitors and verifies compliance with established procedures, work instructions, and current Good Manufacturing Practices (CGMP). Serving as a trusted representative of the Chief Quality Officer and Chief Executive Officer, this role provides accurate, timely, and unbiased reporting on quality-system and operational status. The position works closely with Operations and Quality functions while maintaining independence, discretion, and objectivity. Comprehensive on-the-job training and role-specific materials will be provided.

Job Responsibilities

• Independently verify that personnel follow documented procedures and instructions exactly as written.
• Perform assigned tasks in accordance with work instructions tailored to each Administrator position.
• Conduct structured reviews and follow up on task deadlines, completion, and thoroughness.
• Compare actual practices with applicable procedures, instructions, and checklists; document gaps or discrepancies.
• Initiate a formal Quality Event and, when warranted, a CAPA in the Quality Management System upon identifying findings that meet established severity criteria.
• Track recurring or systemic noncompliance patterns and elevate them for leadership attention.
• Prepare clear, factual reports on task status and findings for joint presentation to the CQO and CEO at least weekly or more frequently as needed.
• Confirm that follow-up actions are completed and incorporated into regular practice.
• Maintain independence from functions under review and report concerns without influence from local operational priorities.
• Handle sensitive and confidential matters with integrity, discretion, and full transparency to executive leadership.

Experience Requirements

• Experience in a disciplined, procedure-driven, and documentation-heavy environment, such as legal or paralegal work, accounting or audit, law enforcement, parole/probation, regulated case management, or a comparable field.
• Demonstrated ability to follow rules, procedures, instructions, and controls precisely and consistently.
• Strong written and oral communication skills, including the ability to document findings factually and without ambiguity.
• Ability to absorb new subject matter quickly and apply critical thinking and logical reasoning.
• High attention to detail and comfort working with checklists, procedures, and cross-referenced data.
• Ability to work independently and report sensitive or unfavorable findings to executive leadership without hesitation.
• Demonstrated objectivity, maturity, integrity, discretion, and resilience when facing peer pressure or competing priorities.
• Prior GMP, pharmaceutical manufacturing, or life-sciences experience is not required; training will be provided.

Education Requirements

Bachelor’s degree in legal studies, accounting, statistics, mathematics, physics, criminal justice, forensic science, or a related field preferred. Equivalent relevant professional experience will be considered in lieu of a degree.