- Job Level:
The Quality Assurance Compliance Officer is an extension of the Regulatory Compliance Department within the Quality Assurance umbrella, responsible for internal, customer, regulatory and vendor audits. Responsible for supporting on-site audits by domestic and international regulatory authorities; reporting directly to the Compliance Manger. This may include oversight of the “War Room” for document staging, preparation, pre-review and discussion with appropriate Subject Matter Experts (SMEs); directing Document Control Group in readiness and response. Generate response to audit observations, as well as tracking, driving, and reporting the status of committed deliverables. The job function includes performing vendor / supplier audits and audit risk assessments in order to evaluate the compliance impact of new suppliers.
- Schedule and conduct audits of vendors, contract service providers, and internal departments.
- Prepare audit agendas, communicate agendas, and respond to follow-up questions.
- Respond to client / regulatory observations and generate audit reports.
- Provide supporting evidence in the determination if a third party facility is GMP compliant.
- Provide follow-up, status updates and / or regulatory communication response / notification to various regulatory bodies.
- Perform regulatory impact assessments for proposed process / product Change Controls and vendor change notifications.
- Send audit questionnaires to selected vendors and follow-up on responses.
- Perform vendor risk assessments and obtain vendor quality agreements.
- Maintain and update approved vendors and contract service providers lists.
- Work with other departments to assure that vendors are approved and able to be utilized.
- Lead and / or Provide assistance for on-site customer audits and regulatory inspections.
- 4 year degree - Science Major Preferred
Experience & Skills Required
- 3+ years with industry experience (within the Pharmaceuticals, Diagnostic, or biotech industries)
- Must be well organized and detail oriented
- Ability to set priorities and work in a fast-paced environment is required
- May be required to wear personal protective equipment