Quality Control Analyst

The Quality Control Analyst II is responsible for day to day operations related to release testing and stability testing. Analyst will perform assays on cGMP manufactured bulk drug substance and drug product material and process intermediates.

Responsibilities include but are not limited to:

Perform the day to day activities for Release Testing/Stability Testing

• Perform various assays testing for protein concentration (including 96-well plate format)
• Performs sampling and analytical testing of raw materials
• Assists in the writing, reviewing, and editing of standard operating procedures
• Individual will assist in maintaining accurate lab inventories and will be responsible for ordering supplies as needed in the lab
• Individual will assist in the maintenance of the lab, which includes routine housekeeping activities.
• Knowledge of cell culture activities is preferred
• Knowledge of HPLC/GC and OpenLab software is preferred
• Knowledge of ELISA/qPCR assays is preferred
• Assists in the authoring and review of laboratory protocols and reports.
• Writing and review of experiments/protocols executed in laboratory notebook
• To ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
• Individual must be able to maintain effective communication with other relevant groups, including but not limited to manufacturing and analytical development
• Individual must be able to aid in method qualification/validation and tech transfer
• Individual must be able to perform OOS/OOT/Deviation investigations in a timely manner and implement the appropriate CAPA's (corrective/preventive actions) to resolve systemic laboratory issues as deemed necessary.
• Individual must be quick to identify and resolve gaps that are identified during day to day
• Other duties as assigned.

Minimum requirements:

• Bachelor's degree in a scientific discipline, or equivalent years of relevant industry experience.
• Minimum 2+ years' experience in a cGMP laboratory, preferably related to pharmaceutical industry operations
• Good communications skills and be conversant in computer systems
• Jobholder should be a good understanding of relevant regulatory/industry standards and requirements

*Please contact Jeff Beckhorn at 301-315-1855 for immediate consideration*

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services.  Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .