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- Goshen, IN
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The Judge Group • Goshen, IN
Posted 16 days ago
Job Req # 591727
FDA Industrial Manufacturing Company is looking for:
POSITION: FDA Quality Auditor
LOCATION: Goshen Indiana (South Bend Area)
EXPERIENCE: 2+ Years Quality Auditing Experience
WORK HOURS: 2pm-10pm M-F
RELOCATION: Assistance Available.
The key to this role is they are looking for someone that typically spends 60-70% of the time on the plant manufacturing floor doing quality control/assurance of products. This is not a LAB position.
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
B.S. in an appropriate Science or Engineering discipline.
Minimum of 2 years of experience required with a B.S. Experience should be in a FDA regulated company with a working knowledge of GMP regulations.
Effective communications (oral/written) and interpersonal skills are necessary.