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University of Pennsylvania
Philadelphia, PA, United States
8 days ago
University of Pennsylvania
Philadelphia, Pennsylvania, United States
8 days ago

Description

This position, Quality Assurance Manager, will carry the oversight responsibility for quality operation of the IND and aNDA radiopharmaceuticals manufacturing at the cyclotron facility of University of Pennsylvania. The QA Manager shall ensure that all GMP related activities in the facility that are consistent and meet both external and internal requirements.

The ideal candidate for this role should demonstrate his/her ability to focus on details, prioritize tasks and organize logically. This person should also be task-oriented and capable of analyzing and solving complex problems. We are seeking someone with a strong understanding in the quality management system and prior experience, and demonstrated record in risk assessment-based approaches. As we work in an interdisciplinary and dynamic environment, the candidate should possess good communication and motivational skills and the ability to adapt and flexible while remaining resourceful and efficient. Prior experiences and knowledge in good manufacturing practice in QA and other relevant regulation are required. 

Accountable for this position are:

  • Batch record, SOP and other regulatory document review and disposition;
  • Review, approval, and release of raw materials, components of in process material or finished product
  • Training program.
  • Investigations of planned and unplanned GMP related deviation and aberrant results.
  • Implementation of corrective action and CAPA plan.
  • Complaints and recalls;
  • Qualification, auditing and compliance oversight of GMP service providers or contractors.
  • Execution and follow-up of internal audit plan.
  • Provide QA input/guidance functional areas as appropriate.
  • Interact with cyclotron facility staff and management team to identify problems and formulate solutions to the identified problems.

QUALIFICATIONS: (Qualifications should clearly indicate those that are required and those that are preferred.)

  • Ability to make difficult, but robust, rationalized and timely decisions based on available data and risk
  • Ability to create a vision and motivate others to achieve that vision
  • Monitors established goals and takes action as needed to ensure timely delivery of goals
  • Minimal BA/BS in science-related major is required.
  • Minimal 5 to 7 year of experience in related field
  • Effective communication and writing skills, effective problem solving skills is required.

Ability to multi-task, work independently and work as part of a team. 



Job Information

  • Job ID: 58138065
  • Location:
    Philadelphia, Pennsylvania, United States
  • Company Name: University of Pennsylvania
  • Position Title: Quality Assurance Manager
  • Industry: Academic Medical Group
  • Job Function: Quality/Risk Management

Please refer to the company's website or job descriptions to learn more about them.

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