On-Board Companies · 20 hours ago
Product Support Scientist (Fluids)
On-Board Companies is an on-site contract service provider for a local manufacturing entity, and they are seeking a Product Support Scientist (Fluids) to support validation activities for new products. The role involves laboratory testing, preparation of clinical test specimens, and maintaining laboratory equipment while adhering to quality and safety guidelines.
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Responsibilities
Support validation activities for new products, including laboratory testing using VITROS analyzers
Prepare and handle clinical test specimens in accordance with approved procedures, best practices, and safety requirements, including proper PPE
Perform pilot-scale formulations with biological materials as needed
Operate and maintain laboratory equipment and complete required documentation in real time (QC records, instrument logs, and test records)
Independently execute laboratory experiments and assist with troubleshooting instrument or test failures
Review and analyze data and document conclusions within quality system
Organize, document, and track long-term studies involving multiple variables, products, and conditions
Maintain working knowledge of cGMP requirements and adhere to all quality, regulatory, and safety guidelines
Qualification
Required
Bachelor's degree in a scientific field (Chemistry, Biology, or related discipline) required
Strong written and verbal communication skills with exceptional attention to detail
Excellent organizational skills with the ability to manage complex, long-term studies
Proficiency in Excel required
Preferred
Experience in an FDA-regulated environment and medical device validation preferred
Familiarity with VITROS products and analyzers highly preferred
Experience with biological formulations and processing techniques highly preferred
Statistical analysis experience preferred
Benefits
401K
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