Quality Assurance Systems Specialist

2 weeks ago

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

Position Overview:

Our client, a dynamic organization with several manufacturing facilities across the United States, is seeking a Quality Management System (QMS) Specialist to support their expansion into pharmaceutical production. This role offers a competitive salary along with relocation assistance and a comprehensive benefits package.

Job Title: Quality Management System (QMS) Specialist

Location: Lawrence, KS

Compensation: Annual salary ranging from $80,000 to $100,000

Relocation: Yes, the client provides relocation support for reasonable expenses.

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

Company Overview: This privately owned firm operates manufacturing sites in California and Kansas, employing approximately 300 individuals.

Team Information: Become part of a medical device and pharmaceutical contract manufacturing team consisting of over 120 employees, with plans for growth to 150 personnel. The Quality division comprises around 25 professionals specializing in Quality Control, Quality Assurance, and Compliance. The selected candidate will oversee the Technical Administration of the Quality Management System – MasterControl and will report directly to the Senior Director – Head of Quality.

Expansion Details: The new operation will focus on Fill Finish Seal – FFS of Sterile Aseptic liquids.

Role Summary:

The organization has adopted QMS software - MasterControl to streamline and integrate quality-related processes, including Training, Document Control, SOP Management, CAPA, Deviation, Change Control, and Audit management.

The QMS Specialist will serve as the Administrator of the QMS system, providing essential support to users across Quality, Production, and Regulatory departments to ensure effective utilization.

This role requires the individual to be a MasterControl Subject Matter Expert (SME).

Key Responsibilities:

  • Manage SOPs to ensure proper user verification and compliance with necessary procedural steps.
  • Oversee Batch Control to confirm adherence to manufacturing processes with appropriate sign-offs.
  • Facilitate Training to ensure all employees receive adequate training and track their progress.

Candidate Requirements:

  • Bachelor's Degree in a related field or equivalent experience.
  • Minimum of 3 years experience in QMS within the Medical Device or Pharmaceutical Industry.
  • Demonstrated ability to manage multiple priorities effectively.
  • Strong multitasking skills with a sense of urgency and ability to meet deadlines.
  • Leadership capabilities to spearhead the QMS implementation.
  • Exceptional attention to detail with a commitment to producing accurate work.

Preferred Qualifications:

  • Familiarity with Sterile Aseptic Filling Operations.
  • Experience in a startup or small company environment in a hands-on role.
  • Background in Contract Manufacturing with a focus on client collaboration.
  • Experience with QMS – MasterControl as utilized by the organization.

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

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