Position Summary:

The Manufacturing Support Specialist I is essential in supporting manufacturing operations and maintaining the sterility and cleanliness of GMP facilities. This role involves aseptic processing of in-house solutions, media and kit preparation, GMP cleaning, and supporting manufacturing cell processing teams. The specialist is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP), performing routine aseptic processing, preparing cleaning solutions for cleanroom sanitization, and ensuring proper documentation for biopsy and product shipments. This role also contributes to maintaining controlled environments, executing cleaning procedures, managing inventories, and collaborating with teams to improve manufacturing processes and cleanliness protocols.

This is located in Winston Salem, NC. The shift is Monday - Friday 10am-630pm with overtime required at times depending on the needs of the business. This is a contractor position and will not be eligible for ProKidney benefits.

Key Responsibilities:

Aseptic Cleaning & Maintenance:

• Perform routine aseptic processing of in-house solutions according to cGMPs, ensuring compliance with all aseptic processing standards.
• Prepare cleaning solutions for sanitizing cleanrooms, following approved procedures and ensuring that cleanroom areas, production zones, and laboratories remain sterile.
• Maintain cleanliness in GMP suites, gowning rooms, biosafety cabinets, and other critical areas to minimize contamination risks.
• Execute GMP equipment cleaning procedures, ensuring that all actions align with current Good Manufacturing Practices.

Documentation & Compliance:

• Complete cleaning logs, batch records, and other required GMP documentation with accuracy, ensuring compliance with FDA and other regulatory bodies.
• Document all activities in alignment with Good Documentation Practices (GDP), ensuring that all relevant records are kept up-to-date.
• Support internal and external audits by providing documentation and verifying compliance with GMP and regulatory standards.

Material & Equipment Management:

• Track and manage inventory of cleaning materials and supplies, ensuring proper storage and reporting of stock needs.
• Maintain and store cleaning tools and equipment appropriately to prevent contamination and ensure readiness for use.
• Prepare product shippers and assist in media and kit preparation, ensuring correct documentation in compliance with Electronic Batch Records (EBR).

Safety & Training:

• Follow safety protocols to maintain a safe working environment and minimize accidents.
• Engage in ongoing training to stay current with GMP regulations and aseptic techniques.
• Report any safety hazards, deviations, or non-conformances to supervisors in a timely manner.

Collaboration & Process Improvement:

• Collaborate with manufacturing, quality assurance, and other teams to ensure effective coordination of cleanliness and regulatory compliance.
• Contribute to the development and improvement of cleaning procedures and manufacturing protocols.
• Assist in data gathering, troubleshooting, and provide support for other tasks within the manufacturing process as needed.

Minimum Qualifications: Education/Training:

• High school diploma or equivalent required; AS/BS in Biotechnology, Biology, Chemistry, or related field preferred.
• Additional certification in aseptic techniques or GMP training is beneficial.
• Relevant experience may substitute for formal education. Experience:
• 0-2 years of experience in biotechnology manufacturing, GMP facilities, or related fields.
• Familiarity with aseptic cleaning procedures and GMP standards is preferred. Skills & Abilities:
• Strong attention to detail, organizational skills, and the ability to multitask in a fast-paced environment.
• Proficiency in aseptic gowning, with the ability to work independently and within a team.
• Experience with strong documentation practices, including familiarity with batch records, logbooks, and compliance forms.
• Effective communication skills, both written and oral, with an ability to follow instructions accurately.
• Ability to stand for extended periods and perform repetitive tasks. Other:
• Strong eye/hand coordination and work ethic.
• Ability to wear protective clothing and equipment, and lift objects up to [specific weight, e.g., 25 pounds].
• Team-oriented mindset with the ability to collaborate effectively across diverse teams. Physical Requirements:
• Ability to stand for extended periods and perform repetitive tasks.
• Capability to lift and move objects up to [specific weight, e.g., 25 pounds].
• Willingness to wear protective clothing and equipment in compliance with GMP standards.