Job Description

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

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