Clinical Operations Specialist - NJ - United States
Responsibilities will include, but are not limited to, the following:
• Act as a senior operator with supervisory presence in the production facility to guide and facilitate the manufacturing of products to support CTDO's clinical and commercial timelines.
• Assume responsibilities as a lead operator for at least one product line, which includes serving as the primary GMP representative during early development and transfer activities.
• Leads the compliance efforts associated with at least two of the major areas of GMP compliance (i.e. Document Management, Batch Record Review, Nonconformance Reporting, Training, Facility Management, Equipment Qualifications/Maintenance, etc...)
o Responsible for systems maintenance, upgrades, and accuracy.
o Addresses related issues as necessary during internal audits.
o Promotes improvements in these areas to achieve greater process efficiencies.
• Assists with development, implementation, and deployment of training to new employees.
• Draft Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Bioprocess Development into Manufacturing Operations
• Represents the department on cross-functional/interdepartmental teams tasked with complex projects
• B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 5+ years of relevant experience in a clinical laboratory or blood/cell culture processing environment or M.S. with 3+ years of relevant experience. Experience in a supervisory or lead role is a plus
• Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs).
• Public speaking/ presentation experience
• Ability to work in an aseptic environment requiring successful completion of qualification program.
• A basic knowledge in various computer applications. Ability to work with Microsoft Word and Excel required. Understanding of Microsoft Access or database entry is preferred.
• Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations.
• Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or flammable chemical reagents and sharps.
• Able to communicate effectively with CTDO functional areas and external agencies.
• Fosters teamwork and promotes an environment that motivates others to achieve our goals.
• Responds to challenges and additional projects in an understanding, positive, and objective manner.
• Adaptable to dynamic conditions, work practices, and project timelines.