Research Scientist

Job Title:

Associate Stability Research Scientist II

12

Months Contract (Potential temp to perm)

$30/hr.

1st shift, M-F (7:30 AM - 4 PM)

The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins. The position provides support to the Stability Group by overseeing all facets of the stability program that are related to oversight of the stability chamber areas, storage, delivery and documentation of the sample inventory in order to maintain a compliant stability program for licensed products and developmental projects, ensuring on-going safety and quality of our products.

• 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 fulfil 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. Performs weekly, monthly, and annual reviews to ensure all equipment remaining compliant, and as a preventative measure to address chamber concerns prior to any impact on studies.

• 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.

• Work is performed in a clinical and/or a laboratory environment.
• Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment.
• Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves.
• Frequently sits and bends neck for 4-6 hours per day.
• May stand and twist neck for 2-4 hours per day.
• Occasionally walks, bends and twists waist and squats.
• Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.
• Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs.
• May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.
• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently works with diverse groups to obtain consensus on complex issues.
• Ability to apply abstract principles to solve complex conceptual issues.
• Performs a wide range of complex tasks as dictated by…