QC Sample Coordination Technician
The primary purpose of this second shift position is to provide support to the sample management group in a QC laboratory setting in support of commercial manufacturing. Responsibilities of the QC Sample Coordination Technician include collating receipt of samples and coordination of testing, preparation of samples using aseptic technique, organizing and tracking lot release data, submission of samples to contract testing laboratories and tracking sample custody. Activities include equipment maintenance, coordinating with Shipping and Receiving, and receipt of test results from contract laboratories.
• Following departmental SOPs, coordinate with internal Manufacturing / QC to perform receipt of samples. Perform supporting sample preparation activities as needed, accurately document all activities performed.
• Perform aseptic processing to prepare samples for testing, process and distribute samples to internal QC labs, prepare samples for shipment to contract testing laboratories, ensure sample integrity and chain of custody is thoroughly documented.
• Coordinate receipt of completed test results, collate and submit for management review and release.
• Provide support for the QC retains program, including inventory management and periodic inspection.
• Perform preventative maintenance and/or equipment monitoring activities, coordinates and schedules equipment maintenance / calibration activities with a third-party provider as needed.
• Monitor the inventory of lab supplies and materials, order as needed.
• Perform other duties as required, work closely with Management regarding work scheduling and assignments. Coordinate outside contract testing.
• Responsible for cleanliness and orderliness of work area, maintains the laboratory in a state of inspection readiness and performs other laboratory maintenance duties as assigned.
• Maintain required training and training records.
• The position is primarily second shift, between the hours of approximately 01:00 and 10:00 PM EST. The sample coordination technician may be called upon to perform additional tasks as assigned by supervisor, during weekend or Holiday hours as needed.
• Minimum of a High School education and 5 years’ work experience in a cGMP manufacturing or testing environment or an Associate’s Degree and a minimum of 2 years’ experience in same or a Bachelor’s Degree in a scientific discipline is required.
• Exceptional attention to detail in documentation, good organizational and time management skills. Familiar with Good Documentation Practices and ALCOA
• Good oral and written communication for effective interpersonal collaboration, with ability to multitask while working under restrictive timelines.
• Ability to work in a team environment and perform job responsibilities with reasonable supervision.
• Knowledge of analytical methods currently used for release and stability testing of biopharmaceutical products.
• Fluency in statistical trend analysis software applications, Windows and Microsoft Office
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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