QC Analyst - Raw Materials

Agilent Technologies•Frederick, CO

7d•$34 - $53

About The Position

Agilent Technologies is expanding its Colorado operations to support the development and commercialization of nucleic acid therapeutics. The QC Analyst - Raw Materials performs sampling and routine and non-routine testing of raw materials in support of manufacturing campaigns, and may support in-process testing for the Frederick team when time allows. Testing includes biochemical and/or chemical analyses and may involve appearance testing, FTIR, identity testing, UV, Karl-Fischer and acid-base titrations, HPLC, LC-MS, GC, GC-MS, NMR, and ICP-M. The analyst calibrates and maintains laboratory equipment; prepares mobile phases, solutions, samples, and standards; manages raw-material sample and retain storage and disposal; participates in investigations; completes on-the-job training; reviews laboratory data; updates SOPs; and may work on analytical and instrument troubleshooting projects. Sampling may occasionally require use of a respirator. The role is scheduled Monday through Friday on day shift.

Requirements

At least 2 years of relevant experience.
Bachelor's degree in Analytical Chemistry or a related life sciences field.
Knowledge of cGMP guidelines and international regulations, including ICH Q7, relating to Quality Control programs supporting API production, stability, and drug-product release.
Knowledge of FDA regulations and guidelines.
Ability to coordinate and handle day-to-day tasks and collaborate to meet deadlines and objectives.
Knowledge of and skill in using computer software and hardware applications, including Microsoft Word and Excel.
Demonstrated knowledge of analytical equipment and instrumentation.

Nice To Haves

HPLC experience in a GMP environment is preferred.

Responsibilities

Sample raw materials, occasionally using a respirator.
Conduct routine and non-routine raw-material analyses to support manufacturing campaigns and, when time allows, support in-process testing for the Frederick team.
Perform biochemical and/or chemical analyses, including bench testing, appearance, FTIR, identity testing, UV, Karl-Fischer titrations, acid-base titrations, HPLC, LC-MS, GC, GC-MS, NMR, and ICP-M.
Calibrate and maintain laboratory equipment.
Prepare mobile phases and other solutions, as well as samples and standards, for raw-material and in-process testing.
Maintain raw-material sample and retain storage and disposal schedules.
Participate in investigations as needed.
Complete on-the-job training, including SOP training and three-step in-lab training on QC jobs.
Review data related to laboratory testing.
Revise and update standard operating procedures as needed.
Perform analytical and instrument problem-solving projects as time allows.