What are the responsibilities and job description for the Quality Tech III position at Mallinckrodt?
Job Title
Quality Tech III
Requisition
JR000014833 Quality Tech III (Open)
Location
St. Louis, MO
Additional Locations
Job Description Summary
Provides technical support at an elevated level by developing solutions to routine problems of limited scope and complexity. Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods.
Job Description
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 and root cause analysis, providing solutions to issues
- Regularly uses communication skills to exchange information, especially technical information within the lab
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- LIMS entry, approval, and data release of products
- Use of analytical balances, HPLC, GC, ICP, KF Titrator, IR, UV, pH Meter, volumetric glassware
- Wet testing like assay titrations, colorimetric tests, TLC, heavy metals, and sieves
- Maintain instrument readiness
- Ability to troubleshoot equipment and methods in areas of proficiency
- Trainer for all areas of proficiency
- Provides guidance and support to team members
- Design Gage R&R experiments
- Identify method improvements and perform change controls
- Ordering of lab supplies
- Identification of cost savings opportunities
- Actively sustains laboratory housekeeping and identifies improvement opportunities
- Completion of hands-on and electronic training
- Participates and leads area huddles or shift meetings
- Other duties as assigned
MINIMUM REQUIREMENTS:
Education:
High School Diploma or equivalent required. Bachelor's Degree in science related field (Chemistry, Biology) is preferred or Associate's Degree with equivalent combination of education, experience, and competencies accepted.
Experience:
Minimum 1-3 years of experience in a cGMP facility
Preferred Skills/Qualifications:
- Adept at wet chemistry testing
- Working knowledge of analytical instrumentation and troubleshooting (GC/LC especially)
- Good technical writing and oral communication skills
- Basic computer skills and familiarity with Microsoft Office Suite
- Substantial acquaintance with and understanding of application of basic lab/analytical principles, theories and concept
- Use and/or Basic knowledge of industry practices and standards
- Use of Chromeleon or other chromatography software
- Previous Pharmaceutical experience is a plus
COMPETENCIES:
Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management, Multi-tasking
ORGANIZATIONL 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:
-
80% 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.
- 20% 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 require
