Quality Auditor (Temp to Perm)

Primary Function:

Performs audits on lines, incoming inspections. Audits batch records, performs internal GMP audits, generates quality reports, and collects data. In the absence of the QA Supervisors or other QA management, communicates to Production and IFS Management.

Specific duties will include:

• Perform quality assurance audits to ensure compliance with QMS, safety and GMP's.
• Approve the release of materials and finished product
• Perform 1st Piece Inspections
• Verify defective returns
• Responsible for verifying brandcode, control group and quantities match ULID or LPN
• Maintain file, records
• Assist QA Supervisor in maintaining training records
• Assists in Temperature and Humidity monitoring and reporting
• Audit quality assurance documentation
• Alert management of any potential problems or non-conformance
• Additional duties as may be assigned

Training/Skills

• Use of scales, measuring tapes, camera, computer, telephone, calculator, and other equipment as needed.
• Strong analytical and problem solving skills
• Strong interpersonal skills
• Strong oral and written communication skills. Fluency in English required. Proficiency in Spanish a plus
• Proficiency in MS Office, including WORD and EXCEL
• FDA experience preferred