Belcan ยท 1 day ago
Clinical Research Associate
Durham, NC
Contract
Onsite
Mid, Senior Level
$37/hr - $43/hr
1+ years expBelcan is a company focused on providing engineering and technical services. They are seeking a Senior Associate Research Scientist II to maintain product inventory for stability studies, ensure compliance with GMP, and facilitate laboratory testing of stability samples.
Enterprise SoftwareIndustrial EngineeringProject ManagementSoftwareTechnical Support
Responsibilities
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
Qualification
Required
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
Company
Belcan
Belcan is a engineering services company offering design, manufacturing, and IT solutions for aerospace, defense, automotive, and more.
5001-10000 employees
H1B Sponsorship
Belcan has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2023 (1)
2022 (4)
2021 (7)
2020 (16)
Funding
Current Stage
Late StageTotal Funding
unknown2024-06-10Acquired
Leadership Team
Dave Brandel
President & COO, Engineering Solutions
David Moya
DIRECTOR OF OPERATIONS
Recent News
2025-10-31
2025-09-30
Company data provided by crunchbase