Associate I, Reagent Compliance Support

Summary/Objective

The Associate I, Reagent Compliance Support functions with minimal supervision and guidance within the Reagent Research and Development Laboratory. The Associate I performs testing activities for IVDR Technical Documentation per approved testing plans. The Associate I is also responsible for writing Technical Documentation that requires scientific knowledge and qualifications, including but not limited to risk management files, datasheets, and reports.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Performs immunohistochemistry (IHC), in situ hybridization (ISH), fluorescence in situ hybridization (FISH) procedures and daily laboratory functions.
• Performs research projects requiring implementation of design files. Writes data sheets and interprets experimental testing results.
• Performs literature searches for experimental and scientific designs pertaining to their work. 
• Writes and edits technical documentation for IVD products. 
• Reviews test forms and other user editable forms of fellow R&D staff members as needed to ensure accuracy of documents prior to submission.
• Other duties as assigned by Management.

Competencies

• Bachelor’s Degree in Biology or a related field; or Associate Degree, with training in Histology & IHC. 
• Zero to five (0-5) years’ Laboratory experience in a related field, or equivalent combination of education and experience.
• Certification as Histotechnician or Histotechnologist preferred.
• Experience in a laboratory environment, with an emphasis on high productivity and multi-tasking to progress on multiple projects simultaneously.
• Hands-on experience in Histology, IHC and automated instrumentation.
• Ability to work independently and manage tasks, while supporting fellow team members. 
• Excellent verbal and written communication skills that produce clear, effective, and complete documentation. 
• Proofreading skills with good attention to details.
• Thorough understanding of product development in an ISO environment.

Compensation Range

• $70,000 - $75,000 annually

Expected Hours of Work

• 8:30 a.m. to 5:30 p.m. Monday – Friday (unless otherwise determined by departmental needs that may include earlier or later starting and ending hours. ). This position may require extended weekday or weekend hours depending on business needs.