Associate Manufacturing

About the role

This fully onsite position supports development, clinical, and product launch activities in a dynamic, highly regulated cGMP-compliant production environment.

Responsibilities

• Perform hands-on manufacturing operations, including equipment set-up, cleaning, sanitization, and monitoring of assigned areas.
• Run and monitor critical process tasks according to established procedures and manufacturing instructions.
• Complete work in strict compliance with cGMP procedures, Standard Operating Procedures (SOPs), Manufacturing Procedures (MPs), Job Hazard Analyses (JHAs), and applicable Code of Federal Regulations (CFR).
• Ensure proper gowning and aseptic techniques are consistently followed to maintain product and environmental integrity.
• Perform in-process sampling, operate analytical equipment, and accurately complete process documentation, including Electronic Batch Records (EBRs).
• Maintain accurate and timely documentation for assigned functions, such as equipment logs and EBR entries.
• Identify and escalate issues or concerns related to daily routine functions, processes, or tasks, and engage with the team on potential solutions.
• Collaborate effectively as part of a cross-functional team, including Quality Assurance, Quality Control, Facilities Engineering, PPIC, Manufacturing, Process Development, Regulatory, and other supporting functions.
• Maintain an organized, clean, and workable production space that supports safe and efficient operations.
• Regularly lift up to 35 pounds, push and pull objects requiring up to 50 pounds of force, and work on your feet for extended periods.
• Perform required physical movements on the production floor, including bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to six feet off the ground.
• Follow all written and verbal instructions precisely and consistently, ensuring adherence to regulated environment requirements.
• Work the assigned rotating 12-hour shift schedule as required by production operations.

Requirements

• High school diploma or GED and at least 2 years of work experience, or an associate degree and at least 6 months of work experience, or a bachelor’s degree.
• Demonstrated ability to follow detailed instructions, SOPs, and work practices in a regulated environment.
• Experience working in or understanding of cGMP and other regulated manufacturing environments.
• Physical ability to lift up to 35 pounds, push and pull up to 50 pounds of force, and remain on your feet for long durations.
• Ability to perform physical movements required on the production floor, including bending, reaching, climbing, kneeling, squatting, stooping, walking upstairs, and working on ladders or portable stairs up to six feet.
• Reliability in working the assigned rotating 2-2-3 12-hour shift.
• Strong commitment to safety, compliance, and proper aseptic and gowning techniques.

Skills

• Ability to learn new processes and procedures quickly, showing strong learning agility.
• Capability to perform repetitive, hands-on production tasks with attention to detail and accuracy.
• Exposure to or training in bioworks or biomanufacturing concepts is beneficial.
• Experience with Electronic Batch Records (EBRs) and equipment logs is an advantage.
• Comfort working with analytical equipment and performing in-process sampling.
• Strong interpersonal skills with the ability to contribute to a positive and supportive team culture.

Work Environment

This role is fully onsite in a manufacturing plant in Holly Springs, NC, following a rotating 2-2-3 schedule with 12-hour shifts from approximately 5:45 AM to 6:15 PM. The environment is highly regulated and cGMP-compliant, requiring proper gowning and aseptic techniques. Team members work with manufacturing and analytical equipment, electronic batch record systems, and standard production tools. The role involves extended periods of standing, walking, and physical activities such as lifting, bending, climbing stairs, and using portable ladders up to six feet. The workspace is maintained in an organized, clean, and safe condition.

Pay

The pay range for this position is $20.00 - $23.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. If eligible, benefits may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)