Nucleus RadioPharma, Inc. Quality Assurance Supply Chain Specialist Rochester, MN · Full time Company website

The Quality Assurance (QA) Supply Chain Specialist position is responsible for oversight, administration, and execution of the Supplier Quality Program in compliance with applicable regulations. This position will require participation in the internal auditing program and supporting site regulatory inspections and customer audits.

Description

PRINCIPAL RESPONSIBILITIES:


  • Conduct risk-based supplier audits, evaluations, and assessments. 
  • Primary supplier quality liaison for clients and internal customers.
  • Issue supplier complaints and drive for resolution and corrective action.
  • Develop and maintain Supplier Quality Agreements and questionnaires.
  • Perform Quality review and approval of supplier-affected Change Controls.
  • Manages onboarding of new suppliers and materials.
  • Manages the site approved supplier list.
  • Perform statistical evaluations to identify trends and report on Supplier Quality metrics (scorecards).
  • Participate and present supplier quality data in Management Review. Determine next steps for suppliers not meeting supplier scorecard metrics.
  • Conduct internal quality audits and develop and assess subsequent corrective action recommendations.
  • Provide support for FDA or other regulatory inspections and customer audits.
  • Provide leadership and coordination on assigned projects.
  • Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
  • Perform other duties as assigned.


MINIMUM QUALIFICATIONS:


  • Bachelor of Science degree in Life Sciences or Engineering required.
  • 5 or more years of relevant Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems working under ICH Q7, GxPs, 21 CFR 210, 21 CFR 211 and/or 21 CFR 212 regulation. 
  • Must have working knowledge in Supplier Quality Management, Supplier Auditing, Supplier Assessment, Supplier Quality Agreements, and Corrective Action.
  • Must have a working knowledge of cGMP guidelines and their application in a controlled aseptic environment.
  • Must have strong technical knowledge in pharmaceutical quality systems with proficiency in the following: Deviations (Non-compliance), Change Control, Internal Auditing, Corrective Action Program, Exceptions, Out of Specification Investigations, Customer Complaints, Regulatory Affairs, Document Management, and Annual Product Reviews.
  • Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation, equipment, processes, and facility systems.
  • Must have working knowledge of Change Management.
  • Must have experience with statistical tools.
  • Proficient in use of Microsoft Suite.
  • Knowledge in other quality systems preferred.


This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”. 

 

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color,

religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.