Quality Control Analyst, Night Shift

Agilent Technologies•Frederick, CO

8d•Onsite

About The Position

The QC Analyst will work on complex problems to drive improvement. This role involves conducting routine and non-routine analysis of raw materials, in-process items, and finished formulations according to standard operating procedures. The analyst will perform biochemical and/or chemical analyses to ensure product stability, compile data for documentation, and calibrate/maintain lab equipment. Responsibilities also include participating in the preparation of investigations, summaries, and reports, potentially developing testing methods, reviewing data for compliance, and revising standard operating procedures. Special projects on analytical and instrument problem-solving may also be assigned.

Requirements

A Bachelor's degree (B.S.) or equivalent in Chemistry or related life sciences field; or equivalent combination of education and experience
2+ years of relevant experience within the Industry
Exposure and knowledge of FDA regulations and guidelines
Knowledge of cGMP guidelines or international regulations (i.e., International Committee on Harmonization (ICH) Q7)
Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples, raw materials, and microbiological samples
Proficient with Microsoft Word, Excel, and Chemstation

Nice To Haves

Experience with in-process analysis utilizing analytical instrumentation for UV Analysis, HPLC, and HPLC-MS is preferred.
Familiarity with the following laboratory disciplines is highly desired: Solution Preparation, UV analysis, HPLC, HPLC-MS.

Responsibilities

Conducts routine and non-routine analysis of raw materials and in-process and finished formulations according to standard operating procedures.
Performs analyses, including biochemical and/or chemical analyses of products, analysis of raw materials, in-process items and finished products to ensure stability according to established operating procedures.
Compiles data for documentation of test procedures that may include biochemical and chemical assays, stability program testing and formulation studies.
Calibrates and maintains lab equipment.
Participates in the preparation of investigations, summaries and reports.
May develop testing methods.
Reviews data obtained for compliance to specifications and reports abnormalities.
Revises and updates standard operating procedures as needed.
May perform special projects on analytical and instrument problem-solving.