Quality Assurance Production Line Auditor II

4 weeks ago


Syracuse, New York, United States Hanford Pharmaceuticals Full time
Job Description

At Hanford Pharmaceuticals, we are seeking a highly motivated and detail-oriented Quality Assurance Production Line Auditor II to join our team. As a key member of our quality assurance team, you will be responsible for performing in-house line audits of pharmaceutical filling and packaging operations, reviewing manufacturing activities and documentation for compliance with SOPs, and generating, reviewing, and issuing batch production records.

Key Responsibilities:

  • Perform in-house line audits of pharmaceutical filling and packaging operations
  • Review manufacturing activities and documentation for compliance with SOPs
  • Generate, review, and issue batch production records
  • Release materials & components for use in production
  • Organize and issue printed materials to production
  • Monitor & interpret charts and gauges
  • Log book review, issuance, and archival

Requirements:

  • Associates degree in Science, or equivalent
  • 3-5 years' experience in or Quality Assurance or Manufacturing, preferably in an FDA regulated environment
  • Working knowledge of cGMPs is preferred

Work Schedule:

Typical 1st shift schedule is 4, 10-hour days. Must be available for various days of the week and a 5-day schedule as indicated. Overtime rates apply to hours over 40 per week. Standard work hours for 1st shift are 6:00 AM - 4:30 PM. Alternative work hours/work schedule may be required at the discretion of management.



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