Manufacturing Research Associate I- R-101188

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to operate equipment, perform SOPs, navigate Document Control systems, ERP systems, etc. This position is Non-Exempt.

Essential Responsibilities:

•  Follow detailed work instructions according to process, product, and Quality System requirements
•  Collaborate with Manufacturing team members and leaders to prioritize and schedule daily production needs
•  Work both independently and in a team environment
•  Perform Incoming QC on raw materials
•  Prepare raw materials for inclusion in finished products
•  Manufacture reagents critical to various nCounter assays and internal processes
•  Manufacture intermediates and finished products
•  Perform QC testing of intermediates and finished products

Requirements:

• BS in Molecular Biology, Biochemistry, or related life science, or 2-year degree plus relevant experience
• 0-2 years of hands-on laboratory experience in a medical device, biotechnology, or academic setting
• Strong analytical, organizational, documentation and communications capabilities
• Ability to handle multiple tasks and meet defined deadlines
• Ability to lift and carry 20-25lb freezer/refrigerator racks
• Willing to work a flexible shift schedule

Preferred Qualifications:

• Experience in either a high-throughput or production environment 
• Familiarity with Microsoft Dynamics NAV or other ERP/MRP system
• Knowledge of ISO-13485, ISO-14971 and/or QSR 21 CFR 820
• Familiarity with Master Control or other EQMS system