Associate Manufacturing Position Available In Wake, North Carolina

Job Title:

Associate Manufacturing Job Description In this vital role, you will be an Associate Manufacturing professional in the manufacturing organization. Your primary responsibility will be to ensure the manufacturing of cGMP (current Good Manufacturing Practices) drug substance. You will complete operations on the floor in the Services area, supporting all floor operations in accordance with cGMP practices. Responsibilities Complete work in accordance with established cGMP procedures, policies, Standard Operating Procedures (SOPs), Manufacturing Procedures (MPs), Job Hazard Analysis (JHAs), and Code of Federal Regulations (CFR) with strict adherence to safety and compliance. Ensure proper gowning and aseptic techniques are always followed. Perform hands-on operation, including set-up, cleaning, sanitization, and monitoring of equipment and assigned area. Prepare and transfer buffer and media. Weigh and dispense materials for the preparation of Buffers and Medias.

Complete washroom activities:

cleaning equipment from small to large scale for use in production activities. Run and monitor critical processes per assigned procedures. Perform documentation for assigned functions, including equipment logs and EBRs. Maintain an organized, clean, and workable space. Essential Skills High school diploma / GED with 1 year of manufacturing and/or other regulated experience, OR an Associate’s degree. Strong verbal and written communication skills. Proficiency in Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems. Additional Skills & Qualifications Completion of NC BioWorks Certificate Program. Experience in a regulated industry such as biotechnology or pharmaceutical. Ability to perform assignments with a high degree of focus and attention to detail. Work Environment The role is fully onsite in Holly Springs, NC. The initial schedule will be Monday-Thursday or Tuesday-Friday, 10-hour days. The schedule will transition to rotating 2-2-3, 12-hour shifts upon completion of startup activities and as business needs dictate.