Quality Compliance Analyst — CGMP & CAPA Reporting

Exela Pharma Sciences; British Woods (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Exela Pharma Sciences is seeking a Quality Administrator to monitor and verify adherence to CGMP and established procedures. The role will report to the Chief Quality Officer and CEO, providing timely, unbiased status updates and maintaining independence in review processes.

Training will be provided, and the position works closely with Operations and Quality functions while upholding discretion and objectivity in all reporting and actions.

Qualifications

• Bachelor’s degree or equivalent professional experience in a related field.
• Experience in a disciplined, procedure-driven, documentation-heavy environment.
• Ability to document findings clearly and objectively.
• Strong attention to detail and ability to follow procedures precisely.

Responsibilities

• Independently verify adherence to documented procedures and instructions.
• Follow work instructions tailored to each Administrator position.
• Conduct reviews and track deadlines and thoroughness.
• Document gaps or discrepancies between practices and procedures.
• Initiate Quality Events and CAPAs when findings meet criteria.
• Track noncompliance patterns and escalate as needed.
• Prepare factual reports for CQO and CEO on a weekly basis.
• Ensure follow-up actions are completed and integrated into practice.
• Maintain independence and report concerns to executive leadership.
• Handle sensitive matters with integrity and transparency.

Skills

Attention to detail

Written communication

Oral communication

Independent work

Problem solving

Education

Bachelor's degree in legal studies, accounting, statistics, mathematics, physics, criminal justice, forensic science, or a related field

Job description

Exela Pharma Sciences is seeking a Quality Administrator to monitor and verify adherence to CGMP and established procedures. The role will report to the Chief Quality Officer and CEO, providing timely, unbiased status updates and maintaining independence in review processes.

Training will be provided, and the position works closely with Operations and Quality functions while upholding discretion and objectivity in all reporting and actions.