Quality Assurance Specialist

at Mallinckrodt
Location Madison, Wisconsin
Date Posted June 22, 2021
Category Bioscience
Job Type Full-time
Address 6603 Femrite Dr


Job Description


The Quality Assurance Specialist is responsible for performing review of GMP documents and batch release as well as supporting the quality system processes and for maintaining quality assurance standards, processes, and controls. The Quality Assurance Specialist is also responsible for providing online support of manufacturing activities, and will occasionally be required to work in a cleanroom environment.

Essential Functions

  • Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product
  • Ensure systems are in compliance with current SOPs and Policies
  • Support internal and external audits as assigned
  • Perform review and release of raw materials, intermediate products and finished products
  • Perform review and approval of Metrology, Maintenance and Validation/Qualification Records
  • Perform review and approval of Environmental Monitoring Records
  • Perform review and approval of OOS, deviation, nonconformance, and investigation as required
  • Assist with writing, revising, and approving standard operating procedures
  • Submit, coordinate, route, and monitor document control activities
  • Coordinate and/or conduct GMP training of peers and or personnel of other departments, as required
  • Scanning/archiving of GMP documents
  • Manage process improvement projects, as assigned
  • May perform additional duties as required

Department specific/Non-essential responsibilities:

  • Support Line Clearance activities and actively participate in Line level QA support

Minimum Requirements

Education / Experience / Skills:

  • Bachelor’s, or higher, degree in a scientific discipline, preferable biology or chemistry
  • 1+ years of experience in a cGMP Quality Assurance/Compliance environment
  • Excellent writing/communication skills
  • Ability to work independently with little supervision
  • Ability to travel is required


  •  Proficient with Microsoft Office tools, especially Excel and Word
  •  Technical writing
  •  Familiarity with Master Control and SAP a plus

Organizational Relationship/Scope:

The Quality Assurance Specialist collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Clinical Quality, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager.  It is the expectation this position works during normal business hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing and Lot Release activities.

Working Conditions:

The Quality Assurance Specialist will mainly work in an office environment but will also be required to work in ISO Class 7 manufacturing and QC environment when providing QA support to those functional areas.

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