NEUROVUE is disrupting the Life Sciences consulting paradigm with a proprietary approach to talent attraction and retention. With focus and extensive investment, NEUROVUE has created an unparalleled employment experience that attracts industry top minds for our clients’ project needs. Through this innovative approach, clients rely upon NEUROVUE for project-based precision and execution.

Our industry demands a firm that continuously develops and provides top talent focused on achieving complex project goals. NEUROVUE is the complete and trusted solution to these specialized talent needs.

NEUROVUE is seeking advanced degree life-sciences professional to serve as a Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.

The primary focus of this role is to perform required analytical and physical quality tests to applicable products, product investigation, and approve finished products. Duties may include one or more of the following: Approves incoming materials meet specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials for re-work and may perform development and validation activities. Maintain compliance with all legal regulations including GMP/ FDA/ISO standards.

Essential Functions and Responsibilities

• Perform daily GMP Quality Control laboratory testing activities with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
• Support product stability programs, including execution of stability testing and final reporting of stability data.
• Initiate and support revisions of documentation, such as SOP, protocols and reports.
• Initiate and support quality records such as deviations, laboratory investigations, CAPAs, and change controls
• Act as a subject matter expert (SME) on one or more assays and train new laboratory personnel
• Support thorough GMP investigations for out-of-specification test results and other quality events.
• Support technical problem-solving for issues pertaining to GMP Quality Control

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control role
• Experience with two or more of the following: Flow Cytometry, Cell based ELISA, NC200