QC Analyst I/II - Full-time / Part-time

Our client in Gaithersburg, MD is in need of a Quality Control Analyst level I or II.

The person will be responsible for performing assay qualification and validation as well as analytical testing on in-process samples, drug substance and drug product for release and in support of stability studies.

Responsibilities include but are not limited to:

* Performs GMP release and stability testing in Quality Control
* Performs day to day activities for cell propagation used for QC assays
* Perform the day to day activities for managing the critical reagents used in QC release assays
* Assist in assay troubleshooting
* Receives, distributes, tracks and coordinates cGMP samples for testing
* Prepares buffers and reagents
* Reviews test records, laboratory notebooks, protocols and reports
* Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
* Participates actively in technology transfer, method qualification and validation
* Gather and analyzes data for final disposition using preapproved documentation
* Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate
* Logs and maintains all references and standards used for testing
* Assists in the writing, reviewing and editing of standard operating procedures
* Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses
* Performs root cause investigation and analysis
* Participates in continuous improvement projects
* Assist in the maintenance of the lab including routine housekeeping activities
* Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
* Other duties as assigned

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Aerotek is acting as an Employment Agency in relation to this vacancy.