Clinical Research Associate

This range is provided by Belcan. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$37.00/hr - $43.00/hr

Job Title: Sr Associate Research Scientist II

Duration: 6+Months contract (Potential temp to Perm)

Shift: 1st shift, Mon-Fri (8am-4:30pm)

Start Date: ASAP

Job Description:

• Daily, maintain product inventory for active stability studies in accordance with all compliance requirements by assuring the accountability and delivery of all stability samples and associated documentation as well as the issuance of required documentation for testing.
• Coordinate with Packaging to acquire samples for batches to be placed into the stability program for evaluation.
• Maintain label printers in good working order to ensure ability to fulfill printing of labels for stability requests.
• Maintain and audit all sample labeling and documentation for accuracy and compliance with GMP.
• Facilitate delivery of stability samples for laboratory testing and coordinate with QC Sample Specialists and stability supervisors to correct any discrepancies associated with stability samples for testing.
• Possess experience necessary to note any uncharacteristic property of the stability samples, as the last viewer of samples before they are sent to the laboratory for testing.
• Track requests for additional samples.
• Generate and review monthly pull schedules for all stability testing for all active studies.
• Generate work orders for preventative maintenance and repairs for all equipment associated with stability incubators to prevent product loss due to equipment failure. Ensure that the Preventative Maintenance program is executed in a timely manner.
• Assure compliance of all completed test request sheets for stability, as applicable.
• Experience in conducting a check-in process for receipt of data, when applicable, for data returned from the testing laboratories.
• Experience with entering test data into the stability databases, Stability System and/or SAP
  .
• Assist with filing of all stability records.
• Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory.
• Remove samples from inventory and perform required documentation for completed stability studies.
• Initiate purchase orders and work orders for the Stability Group.
• Performs shipment of samples between sites.
• Trains Stability staff on sample handling and inventory procedures.
• Perform daily assessments of operation of the stability incubator and freezers.
• Conduct investigations for any excursions outside validated ranges (temperature for the stability incubators.
• Analyzes chamber temperature and humidity trends daily to evaluate for any issues.

Requirements:

• This position requires MS Degree/BS + 1-2 years
  /No degree + 5 years experience (for the Associate Stability Research Scientist II position).
• Educational degrees and experience must be relevant to the position
  , i.e. college degree with emphasis in a scientific field and/or experience in the regulated pharmaceutical industry in a stability program.

• Associate

• Contract

• Research and Quality Assurance

• Biotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care

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