Job Title

Quality Tech III

Requisition

JR000014684 Quality Tech III (Open)

Location

Fenton, MO

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

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.

ESSENTIAL FUNCTIONS:

Follow good documentation practices for the accurate and timely documentation of all activitiesPerform wet chemistry and instrumentation testingFollow site HSE PoliciesPeer review all levels of workAbility to conduct OOS Investigations providing root cause analysis and corrective action for Out of Specification ResultsGenerate and review proposed changes to specifications (SMMs) through the change control systemAbility to perform instrument maintenance and troubleshoot chromatography issuesAssist with establishing & maintaining safe work standards in Lab, and identifying & executing safety improvements and waste minimization opportunitiesPerform data release of all productsRegularly uses communication skills to exchange information, especially technical information within the lab

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

LIMS entry, approval, and data release of productsUse of analytical balances, HPLC, GC, ICP, KF Titrator, IR, UV, pH Meter, volumetric glasswareWet testing like assay titrations, colorimetric tests, TLC, heavy metals, and sievesMaintain instrument readiness Ability to troubleshoot equipment and methods in areas of proficiencyTrainer for all areas of proficiencyProvides guidance and support to team membersDesign Gage R&R experimentsIdentify method improvements and perform change controlsOrdering of lab suppliesIdentification of cost savings opportunitiesActively sustains laboratory housekeeping and identifies improvement opportunitiesCompletion of hands-on and electronic trainingParticipates and leads area huddles or shift meetingsOther 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: Minimum 1-3 years of experience in a cGMP facility

Preferred Skills/Qualifications:

Adept at wet chemistry testingWorking knowledge of analytical instrumentation and troubleshooting (GC/LC especially)Good technical writing and oral communication skillsBasic computer skills and familiarity with Microsoft Office SuiteSubstantial acquaintance with and understanding of application of basic lab/analytical principles, theories and conceptUse and/or Basic knowledge of industry practices and standardsUse of Chromeleon or other chromatography softwarePrevious 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:

80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compoundsRequires use of PPE for lab environment and potential handling of controlled substancesPrimarily standing and walking within the building, but also requires some walking between buildings, stairs, and lifting.20% Office environmentRequired 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.