The contract Chemist III position will act as a senior member of the QC Analytical team, supporting raw material and finished product release, method qualifications (verifications, transfers, validations) and stability studies.
The Chemist III will execute chromatographic (LC / GC), spectroscopic and wet chemistry testing. As a senior member of the team, the Chemist III will also assist with technical writing (Quality Investigations, Methods, Reports) and participate in lab improvement initiatives.
Assists junior members of the team as chromatography trainer and technical expert.
Contract : 4-6 months duration
Responsibilities
- Perform QC chemistry testing to support routine manufacturing activities, new product method development and stability testing.
- Participate in protocol design for qualification of new methods and subsequent authoring of new procedures.
- Use technical expertise in LC / GC to troubleshoot new methods and improve existing procedures. Able to diagnose and make minor repairs.
- Perform testing in compliance with relevant regulations. All activities are performed in GMP / GDP environment.
- Assist in the performance of internal and external audits.
- Assume role of SME and trainer for individual techniques / instrumentation, including chromatography.
- Maintain the laboratory working areas in a clean and organized state.
- Provide technical support to other departments within the organization.
Required Knowledge, Skills and Abilities
- Must have strong communication and interpersonal skills.
- Knowledge of quality systems, FDA and compendium requirements
- Experience executing method qualifications in a GMP environment.
- Wide range of analytical chemistry experience (chromatography, spectroscopy, wet chemistry, etc.).
- Demonstrated excellence in LC / GC analyses.
- Competency with routine software programs (i.e. MS Word, MS Excel).
- Ability to learn complex software programs (i.e. Labware LIMS, Empower 3).
Required Education and Experience
- At least a B.S / M.S in Chemistry
- 8+ years of experience in a Chemistry Laboratory
- 5+ years of Experience in a GMP QC Laboratory
- 2+ years Leadership Experience (preferred)
- Experience in Customer-focused Laboratory Environment (Preferred)
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