Quality Assurance Systems Specialist

1 week ago


Lawrence, Kansas, United States Management Recruiters of Edison Full time

Company Overview: Our client is a dynamic organization with several manufacturing facilities across the United States, currently seeking a Quality Management System (QMS) Specialist to support their expansion into pharmaceutical production.

Position Summary: This role offers a competitive salary along with relocation assistance and a comprehensive benefits package.

Job Title: Quality Management System (QMS) Specialist

Location: Not specified

Compensation: Salary range of $80,000 - $100,000 annually

Relocation: Assistance provided for reasonable expenses

Benefits: Comprehensive medical and dental insurance, 401K plan, and 13 days of paid time off.

About the Organization: This privately owned company operates manufacturing sites in multiple states and employs approximately 300 individuals. The Quality team consists of around 25 professionals focused on Quality Control, Quality Assurance, and Compliance.

Role Responsibilities: The selected candidate will oversee the Technical Administration of the Quality Management System – MasterControl and will report directly to the Senior Director of Quality.

The new operation will focus on the Fill Finish Seal (FFS) of Sterile Aseptic liquids.

Key Duties Include:

  • Administering the QMS software, MasterControl, to facilitate quality-related functions such as Training, Document Control, SOP Management, CAPA, Deviation, Change Control, and Audit Management.
  • Providing support to users across Quality, Production, and Regulatory departments to ensure effective utilization of the QMS.
  • Acting as a Subject Matter Expert (SME) for MasterControl.
  • Managing SOPs to verify user compliance and ensuring proper process sign-offs.
  • Overseeing Batch Control to confirm adherence to manufacturing processes.
  • Tracking employee training progress to ensure all personnel receive appropriate training.

Qualifications:

Required:

  • Bachelor's Degree or equivalent experience.
  • Minimum of 3 years of experience in Quality Management Systems within the Medical Device or Pharmaceutical industry.
  • Strong organizational skills with the ability to manage multiple priorities.
  • Proven ability to meet deadlines with a sense of urgency.
  • Leadership capabilities to effectively implement the QMS.
  • Attention to detail and a commitment to delivering accurate work.

Preferred Qualifications:

  • Familiarity with Sterile Aseptic Filling Operations.
  • Experience in a startup or small company environment.
  • Background in Contract Manufacturing with a focus on client relations.
  • Experience with QMS software, particularly MasterControl.

Keywords: BioPharma, Pharma, Quality, FDA, QMS, MasterControl, Sterile, CDMO, Manufacturing.



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