Manager of QA

11/21/23

Omaha, NE

2191

FullTimeRegular

The Manager of Quality Assurance is responsible for oversight and management of Operational Quality Assurance resources. The Manager of Quality Assurance will interact with different levels of management and personnel within each department.

Responsibilities:

  • Responsible for the oversight of Operational Quality Assurance to be compliant with Quality Policies and Standards
  • Provide management and leadership for scheduling and assignment of Operational Quality Assurance technicians to support operational activities.
  • Manage Environmental Program.
  • Write, review and/or approve Deviations, Change Controls and Manufacturing Instructions.
  • Release in process and finished products.
  • Conduct/assist in investigations of deviations and CAPAs; Out of Specifications (OOS’s) for Release/Stability and Out of Trends (OOT’s).
  • Prepare and communicate assigned Quality System key performance indicators and trending.
  • Support QC testing and sample management program.
  • Identify and execute quality related processes and projects

Requirements:

  • Minimum High School diploma, GED or equivalent required.
  • Bachelor’s degree in science preferred.
  • Minimum of 5 years of experience with US FDA and cGMP requirements.
  • Minimum of 5 years of experience with Quality Assurance and/or Quality Control practices.
  • Advanced understanding of manufacturing in cGMP environment, documentation and data integrity requirements.
  • Experience with computer system and Microsoft program.
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, pharmaceutical environment
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences.
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