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- Goshen, IN
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The Judge Group • Goshen, IN
Posted 10 days ago
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Job Req # 603436
FDA Industrial Manufacturing Company is looking for:
POSITION: Regulatory Quality Auditor
LOCATION: Goshen Indiana (South Bend Area)
EXPERIENCE: 2+ Years Quality Auditing or Regulatory Investigations Experience
WORK HOURS: 3pm-11pm M-F
RELOCATION: Relocation Assistance Available.
NO H1B OR VISA CANDIDATES
Keys to this role:
- Candidate must have some type of FDA, Pharmaceutical or Food/Beverage Regulatory Auditing and Investigation experience
Under the direction of GMP supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs)And other applicable worldwide regulations.
Review and approve production and analytical documentation accompanying the release to ensure conformance to appropriate regulatory requirements.
In addition, the Auditor communicates and resolves audit comments with client areas.
Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Client standards.
Issue reports summarizing deficiencies and work with areas to execute remedial action.
Notify appropriate management of inspection results