Quality Assurance Manager
4 weeks ago
We are seeking a highly skilled Quality Assurance Manager to lead our manufacturing quality assurance activities. The successful candidate will be responsible for directing and managing the MQA team, overseeing daily product manufacturing and lot release, and ensuring that all products meet regulatory, corporate, and customer standards for quality, safety, and efficacy.
Key Responsibilities:
- Direct and manage the Manufacturing Quality Assurance activities, including on-the-floor batch record review and 24/7 Quality Assurance oversight of manufacturing processes.
- Provide manufacturing and Quality Assurance technical expertise to internal departments.
- Develop and implement quality and compliance process improvements and goals for the sites.
- Lead effective and efficient continuous quality and cost improvement efforts.
- Hire, train, and develop MQA staff and conduct Performance Reviews.
Requirements:
- Bachelor's degree in Science, Chemistry, Biology, or related field of study.
- Minimum of five years in Quality Assurance or Regulatory Compliance Management.
- Minimum of two years in a leadership role.
- Minimum of five years in an aseptic/sterile product facility.
Working Environment:
The working environment will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. The pharmaceutical manufacturing environment is sterile, and aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes, and powered air purifying respirators) is necessary, depending upon the task at hand.
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