Manufacturing Associate, Bulk Drug Substance - Holly Springs, NC

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
• Affirm compliance with cGMP practices
• Assure proper gowning and aseptic techniques are always followed
• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
• Run and monitor critical process tasks per assigned procedures
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
• Document for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
• Maintain an organized, clean, and workable space

Requirements

• High School/GED + 2 years manufacturing and/or other regulated environment experience
• Or Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
• Or Bachelor’s Degree

Qualifications

• Completion of NC BioWorks Certification Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding and process experience in a cGMP manufacturing facility
• Excellent verbal and written communication
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Pay

$75,000 - $100,000 annually

Schedule

Rotating 2-2-3, 5:45AM-6:15PM (12-hour shift)