Role - QC Analyst

Location - Onsite in Sellersville, PA

Duration - 6 months

Pharmaceuticals Experience

Work schedule/typical work week/daily start and end time:

• First shift, 8am 4pm
• OT should b e expected and the opportunity to pick up weekend work

Client description:

• CDMO providing a complete end to end solution for the development and manufacture of oral dosage and topical pharmaceuticals.
• They have recently onboarded three new clients and are expanding operations.

Project description:

This QC team is responsible for running all QC analytical testing for pharmaceutical raw material and finished product at the Sellersville location. Currently there are more than 25 different product lines.

• 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.
• Interpretation QC analytical testing data to the QC Data Review team and Manufacturing stakeholders.
• This role will be responsible for the bench testing and wet chemistry activities of raw materials and finished products.
• This role will also be responsible for HPLC and GC. This includes all steps of sample and equipment prep, sample analysis and system troubleshooting if issues are identified.

Technology environment the consultant will be working in:

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

Consultants day to day responsibilities:

• Bench testing of raw materials and finished products using Waters Empower HPLC, Malvern Particle Size Analyzer and Karl Fisher Titration.
• Performing wet chemistry testing including viscosity, pH and dissolution.
• Documentation of results into LabVantage LIMS.
• Developing trend reports
• Review of chromatograms for accuracy.