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 escalate 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.
EOE, including disability/vets
