We are currently recruiting for a GMP Auditor/Sr GMP Auditor (Remote) who will be responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.
A typical day in this role might include the following:
- Schedules, prepares, and conducts audits in support of GMP as directed.
- Assembles and coordinates the activities of the audit team.
- Conducts audits in accordance standard operating procedures and quality policies.
- Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
- Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
- Escalates any compliance issues.
- Communicates audit results to management and auditees through written audit reports.
- Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts.
- Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
- Drafts and issues periodic reports to site management as requested.
- Assists with training/orientation for new Quality Auditing staff.
- Supervises junior auditors.
- 50% Domestic and international travel required for this role.
To be considered for this role you must hold a Bachelor’s degree with 2-5+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment preferred. Other proven experience may be considered in lieu of degree. Level is determined based on qualifications relevant to the role.