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Description:

We are seeking a Quality Control Analyst to join our Quality Control team in Rockville, MD. Qualified individuals 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

Analytical methods include: UV Spectroscopy, RP-HPLC, BCA, qRT-PCR, ELISA, SDS-PAGE, Capillary Electropheresis

• 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

• Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate

• Assists in the writing, reviewing and editing of standard operating procedures

• 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

Skills:

quality control, GMP, sds page, ELISA, HPLC, gel electrophoresis, qRT-PCR, qPCR

Top Skills Details:

Quality Control

GMP

ELISA

SDS-PAGE

Additional Skills & Qualifications:

Minimum requirements:

• BS degree with a minimum of 3 years laboratory experience in Biological Sciences

• Knowledge and expertise in principles and practices of current Good Manufacturing Practices (GMPs).

• Knowledgeable in FDA regulations regarding the manufacturing of biologicals.

• Good aseptic technique is essential for this position.

• Proficient in Windows based software to include Excel and Word.

Experience Level:

Expert Level

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.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.