Sr. QC Analyst

Monday-Friday, 12pm-8pm

Project description:

· Performance of all QC analytical testing for raw material, finished product and environmental monitoring samples.

· Providing analytical method support and equipment troubleshooting to QC staff in the lab.

· Test instrumentation and methods include HPLC, GC, Dissolutions, Particle Size Analyzer, FTIR (Fourier Transform Infrared) Spectroscopy, pH, Dissolution Testing, Viscosity and TOC (Total Organic Carbon) Testing.

· Responsible for the bench testing and wet chemistry activities of API, raw materials and finished products.

· Responsible for HPLC and GC testing. This includes all steps of sample and equipment prep, sample analysis and troubleshooting chromatography equipment issues.

· Participating in and performing deviation investigations and supporting the writing/documentation of findings.

Technology environment the consultant will be working in:

• Waters Empower, HPLC and GC
• Malvern, Particle Size Analyzer
• Karl Fischer Method
• Dissolution testing
• LabVantage LIMS

Consultants day to day responsibilities:

• Performing bench testing of raw materials and finished products using GC, HPLC, Malvern Particle Size Analyzer and Karl Fisher Titration.
• Review of chromatograms for accuracy and identification of potential chromatography issues

· Providing analytical method support and equipment troubleshooting to QC staff in the lab.

• Determine root cause
• Isolate the issue
• Check historic baselines
• Performing wet chemistry testing: viscosity, pH and dissolution.
• Visual inspection of samples
• Documentation of bench tests and wet chemistry results into LabVantage LIMS.
• Developing trend reports to share with QC Data Review team

Required Skills:

· Bachelor’s degree in Chemistry, Biochemistry or related field.

o Previous experience reviewing analytical testing data in a non-academic setting.

o Previous experience doing analytical testing in a commercial production or CDMO environment

o Prior experience identifying and troubleshooting QC analytic methods and equipment issues. Some examples:

§ HPLC – Baseline noise, drift, peak tailing, system backpressure

§ GC – Retention times, peak sensitivity

§ Karl Fischer – baseline drift, over-titration

§ Dissolution – Paddle speed, release data issues

o Previous experience performing analysis using HPLC:

§ Ability to choose the correct solvent for the material being tested

§ Ability to prepare the sample for testing, including extraction, concentration or dilution

§ Ability to clean and load the column.

§ Ability to calibrate the HPLC

§ Ability to use both the Manual Injection and Autosampler

o GC, Dissolution Testing and Particle Size Analysis

o Ability to analyze and interpret a chromatogram.

§ Identify common issues, including Poor Peak Shape, Poor Peak Resolution, Poor Reproducibility, Baseline Drift.

Pay: From $60.00 per hour

Benefits:

• Dental insurance
• Health insurance

Work Location: In person