Manager, Quality Assurance

Sharp Services

Allentown, US
On-site
Supervision of quality activities
Cgmp compliance
Customer interface for quality issues
Sharp Services is seeking a Manager of Quality Assurance for their Allentown facility. The role involves supervising quality activities, ensuring compliance with cGMP standards, and liaising with customers regarding quality issues

Job Summary

  • Responsibilities include supervision of quality activities, assessment for new and ongoing projects, and providing direction for cGMPs to direct reports.
  • Responsible for contact with QA representatives from each customer regarding quality issues related to documentation, inspection, and packaging process, and participate in audits by customers and other regulatory agencies.
  • Scope of the position is focused on the Allentown facilities, with decisions impacting customer interface, quality inspections, and documentation requirements potentially exposing the company to significant risk or economic loss.

Matching Summary

Match Score: 85

Sharp Services is seeking a Manager of Quality Assurance for their Allentown facility. The role involves supervising quality activities, ensuring compliance with cGMP standards, and liaising with customers regarding quality issues.

Skills & Requirements

Must-have

  • Supervision of quality activities
  • cGMP compliance
  • Customer interface for quality issues
  • Internal operations collaboration
  • Investigate deviations and complaints
  • SOP review and revision
  • Label Room management

Nice-to-have

  • Problem-solving initiatives
  • Training of floor staff
  • Environmental monitoring compliance
  • Calibration program compliance
  • Master Packaging Records development

Key Requirements

  • Bachelor's degree in Science (BS/BA) or 5-10 years related experience
  • Knowledge of FDA regulations including cGMPs
  • Thorough knowledge of quality control/assurance
  • Above average written and oral communication skills
  • Above average organizational and planning skills
  • Proficient in Microsoft Office Suite

Work Rights

Not specified

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