A Compliance Auditor examines records and procedures to determine adherence to regulatory guidelines of an organization. Inspects accounting, IT or security, prepares reports on the compliance with required regulations and risk management procedures.
Genie Hooper This information is for internals only. Please do not share outside of the organization.
Your Role:
Quality Specialist 3 - GMP/GLP Compliance provides independent quality oversight within a GMP/GLP-regulated laboratory environment. This role ensures compliance with regulatory requirements, internal procedures, and client expectations through investigation management, risk-based decision making, audit support, inspection readiness, and continuous improvement. The position partners with operational, technical, and client stakeholders to maintain an effective and inspection-ready Quality Management System (QMS).
Key Responsibilities:
Lead or support client, internal, regulatory audits and inspections. Lead audit preparation, audit response, and tracking of outstanding compliance initiatives. Drive inspection readiness activities and track audit commitments, CAPAs, and compliance actions. Review, approve, and/or lead deviations, investigations, CAPAs, effectiveness checks, change controls, and risk assessments. Serve as a subject matter expert for root cause analysis (RCA) and quality investigations. Interpret regulatory requirements and provide compliance guidance to operational teams. Review and approve SOPs, GMP records, and other quality documentation. Facilitate risk assessments using tools such as HACCP and FMEA. Monitor quality metrics and trends, identify systemic issues, and lead continuous improvement initiatives. Support client meetings, regulatory submissions, supplier qualification activities, and client quality agreements as needed.
Who You Are :
Minimum Qualifications:
Bachelor's degree in a life science discipline. 2+ years' experience in conducting internal audits, client audits, or Client quality agreements in a Quality Assurance role. 2+ years' experience in leading and/or reviewing root cause analysis and CAPA for deviations in a Quality Assurance role
Preferred Qualifications:
Experience in a GxP CRO/CDMO/CTO or multi-client environment. Experience with inspection readiness programs and regulatory responses. Experience analyzing compliance metrics and quality trends. Working knowledge of
FDA 21 CFR
Parts 58, 210, 211, Part 11, EU GMP requirements, and
ICH Q9/Q10.
Broad quality systems experience across multiple QA disciplines. Experience in conducting supplier audits Demonstrate proven track record of effective communication with internal stakeholders and external clients. Strong analytical, communication, organizational, and problem-solving skills. Demonstrated ability to work independently, influence stakeholders, and foster a culture of quality and compliance.
Pay Range for this position:
$70,800-106,200 annually The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here . The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
