Job Title: Associate Manufacturing

Job Description

In this vital role, you will work as an Associate Manufacturing professional within the manufacturing organization located in Holly Springs, NC. You will play a crucial role in completing floor operations in the Services area and are responsible for the manufacturing of cGMP drug substance. Initially, the schedule will be Monday-Thursday or Tuesday-Friday, with 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.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies, including 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 operations including set-up, cleaning, sanitization, and monitoring of equipment and assigned areas.
• Prepare and transfer buffer and media.
• Weigh and dispense materials for the preparation of buffers and medias.
• Complete washroom activities, including cleaning equipment for small to large scale use in production activities.
• Run and monitor critical processes as per assigned procedures.
• Perform documentation for assigned functions, such as equipment logs and Electronic Batch Records (EBRs).
• Maintain an organized, clean, and workable space.

Essential Skills

• High school diploma or GED with at least 1 year of manufacturing or other regulated experience, or an Associate's degree.
• Basic understanding of GMP principles.
• Strong verbal and written communication skills.
• Proficient in Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Ability to perform assignments with a high degree of focus and attention to detail.

Additional Skills & Qualifications

• Completion of NC BioWorks Certificate Program.
• Experience in a regulated industry such as biotechnology or pharmaceutical.

Work Environment

This is a fully onsite position in Holly Springs, NC. The initial schedule will be Monday-Thursday or Tuesday-Friday, with 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.