QC Analyst - Raw Materials
Job Description
The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.
- Performs sampling of raw materials (occasionally with the use of a respirator).
- Conducts routine and non-routine analysis of raw materials to support the manufacturing campaigns. When time allows, this analyst will also support in-process testing to support the Frederick team.
- Performs analyses, including, but not limited to, biochemical and/or chemical analyses of raw materials, in lab bench testing of raw materials, appearance, FTIR, Identity testing, UV, Karl-Fisher titrations, Acid-Base titrations, HPLC, LC-MS, GC, GC-MS, NMR, ICP-M
- Calibrates and maintains lab equipment. Makes mobile phases and other solutions to support raw material testing and other in process testing. Prepares samples and standards to complete lab analyses.
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Maintains raw material sample/retain storage and disposal schedule.
Participates in investigations when needed.
Completes on the job training including training on SOP's and 3-Step in lab training on all QC JOB's.
Reviews data related to all lab testing.
Revises and updates standard operating procedures as needed.
May perform special projects on analytical and instrument problem-solving as time allows.
Shift: Day Shift, Monday-Friday
Qualifications
- 2+ years of relevant experience for this level
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Bachelor's degree (B.S.) Analytical Chemistry or related life sciences field.
- Knowledge of cGMP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support production of APIs, stability and drug product release
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Knowledge of FDA regulations and guidelines
Skills in coordinating and handling day to day tasks and working in collaboration to accomplish deadlines and objectives
Knowledge of and skilled in using computer software and hardware applications, including Microsoft Word and Excel
- Demonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred
Additional Details
Travel Required
Shift
Duration
Job Function
Not included in the source posting: about the role, qualifications, benefits.
Skills
Who can apply
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