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Quality Tech II

Mallinckrodt Pharmaceuticals
United States, Missouri, Fenton
Jan 05, 2025

Job Title

Quality Tech II

Requisition

JR000014683 Quality Tech II (Open)

Location

Fenton, MO

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods.

ESSENTIAL FUNCTIONS:

  • Follow good documentation practices for the accurate and timely documentation of all activities
  • Perform wet chemistry and instrumentation testing
  • Follow site HSE Policies
  • Assist with establishing & maintaining safe work standards in the lab
  • Peer review all levels of work
  • Conducts lab investigation
  • Uses communication skills to exchange information

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

  • LIMS entry and approval of data
  • Use of analytical balances, HPLC, GC, ICP, AA, KF Titrator, IR, UV, pH Meter, volumetric glassware
  • Wet testing like assay titrations, colorimetric tests, density, conductivity, TLC, heavy metals, and sieves
  • Maintain instrument readiness
  • Actively sustains laboratory housekeeping
  • Completion of hands-on and electronic training
  • Participates in area huddles or shift meetings
  • Other duties as assigned

MINIMUM REQUIREMENTS:

Education: High School Diploma or equivalent required. Bachelors Degree in science related field (Chemistry, Biology) is preferred or Associates Degree with equivalent combination of education, experience, and competencies accepted.

Experience: Working knowledge of wet chemistry required

Preferred Skills/Qualifications:

  • Working knowledge of analytical wet testing and/or instrumentation.
  • Experience in a cGMP environment is preferred.
  • Basic computer skills and familiarity with Microsoft Office Suite
  • Acquaintance with and understanding of application of basic chemistry/analytical principles, theories and concept
  • Use and/or Basic knowledge of industry practices and standards
  • Chromatography (GC/LC) and Spectroscopy experience a plus
  • Use of Chromeleon or other chromatography software is a plus
  • Previous Pharmaceutical experience is a plus

COMPETENCIES:

Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management, Multi-tasking

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Reports to the Supervisor Quality Testing. Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters.

WORKING CONDITIONS:

  • 90% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds
    • Requires use of PPE for lab environment and potential handling of controlled substances
    • Primarily standing and walking within the building, but also requires some walking between buildings, stairs, and lifting.
  • 10% Office environment
  • Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the business needs

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

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