Job Title: Quality Specialist - I (analytical testing)
Duration: 06 Months
Location: Elkton, VA 22827
Shift:
- Rotating shift will look like the following: (Week 1 - Mon, Thurs, Fri - 12hr days) / (Week 2 - Tues, Wed, Sat - 12hr days, + Sun - 8hr day), then rotation starts over again.
- Start times are roughly between 7am-8am
Qualifications:
- Education: Bachelors degree preferred, will consider Master's degree if applicable to role.
- Ability to perform a variety of chemical analysis on drug substances which include: instrumental analysis using HPLC and ICP.
- Familiarity performing plate reader based assays, qPCR, Dynamic Light Scattering and gel electrophoresis.
- Minimum 1+yrs of experience utilizing the listed methods and working within a GMP laboratory.
- Ability to work a 12hr rotating shift with 2 week cadence
Responsibilities:
- Perform analytical testing in the Quality Control laboratory on a variety of samples/products
- Conduct testing such as plate reader based assays, gel electrophoresis, dynamic light scattering, qPCR, ICP and HPLC.
- Ensure test data is accurate and that all work is Right-First Time
- Work with team members to ensure the highest levels of cGMP compliance and inspection readiness
- Assist in laboratory related activities such as second person review, instrument calibration and troubleshooting, deviation investigations
- Interact and understand various data acquisition/management software