Chemist I

Job Title: Chemist I
Job ID: 18047-1
Location: Arden Hills, MN
Duration: 12 months
Payrate: $35.00-40.20/hr

Important to have :
Sample solvent extracts of medical devices
Pipettes
Laboratory balances
Working with hoods
Storage equipment, Dishwashers
Chemistry - (biochemistry, okay) degree
Must have lab experience, internships, chemistry stockroom experience, wet/bench chemistry prep experiences are great!
Extractables and Leachables experience (E&L) or chem characterization
Medical device/pharma ---FDA experience, regulated environment
Medical device or pharmaceutical company analytical chemistry lab work experience, especially in chromatography characterization and investigative analyses.

Lab coat and safety glasses will be provided.
Must wear closed toed shoes, and pants. No shorts.

Due to type of chemicals being used, a pre-medical screening will be required prior to start.

Job Purpose :
Support chemical characterization testing of medical devices. Apply chemistry skills in standard and sample preparation. Initiate instrumental testing using FTIR, GCMS, LCMS, or ICPMS techniques.

Key responsibilities :
Perform hands-on testing in the analytical chemistry laboratory, including sample preparation (extractions, solvent exchange, concentration), gravimetric determination of non-volatile residue, and standard preparation
Support development, validation, and qualification of analytical methods
Prepare analysis summary reports/documentation to communicate results to lab customers and the technical community
Complete tasks on analytical lab documentation and quality records
Support qualification and maintenance of analytical instrumentation
Complete lab maintenance activities such as ordering, glassware washing, and other lab monitoring activities
Familiarity with ISO 10993, ISO 17025, FDA, and other regulatory agency requirements for chemical characterization of medical device and combination products
Apply scientific principles and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Qualifications :
BS in Chemistry with aptitude for analytical chemistry.
0-2 years of experience - post graduate with internship(s) count!
Experience in preparation of samples, standards, and laboratory solutions
Strong organizational, communication, and collaboration skills
Strong technical writing and scientific laboratory documentation skills

Preferred Qualifications :
Exposure to Chromatography Data Systems
Experience with chemical characterization analysis per ISO 10993
Experience with HPLC or GC instrument analysis and troubleshooting
Experience applying ISO 10993 and ISO 17025 requirements to laboratory work
Working experience in performing analyses and preparing documentation within FDA, ISO 17025, and other regulatory environments
Medical device or pharmaceutical company analytical chemistry lab work experience, especially in chromatography characterization and investigative analyses.