ProKidney
Manufacturing Support Supervisor
Winston-Salem, North Carolina, United States
Work authorization requiredDetected 26 days ago
Supply ChainERPGMPLeadershipCommunicationProblem SolvingMentoringWriting
About the role
- The Manufacturing Support Supervisor provides front-line supervision for the manufacturing support function, ensuring safe, compliant, and reliable execution of daily operations in accordance with cGMP requirements. This role coordinates core support activities including media preparation, material kitting, and GMP cleaning to enable on-time manufacturing
- execution by following the approved schedule and standard work. The supervisor assigns daily work, supports training and qualification compliance, addresses routine operational issues, and escalates constraints, deviations, and staffing concerns to management as appropriate. This position partners with Manufacturing, Quality, Supply Chain, Training, and
Requirements
- Bachelor's degree or equivalent experience in a related field (e.g., Life Sciences, Manufacturing, or Engineering)
- Minimum 4+ years of experience in a manufacturing or GMP environment
- 2+ years of experience in lead, training, or coordination role
- Knowledge/Skills
- Strong knowledge of GMP guidelines, safety protocols, and regulatory requirements
- Ability to work in a fast-paced environment while maintaining high standards of quality and compliance
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
- Support internal and external audits and inspections by ensuring documentation readiness for the shift and by completing assigned follow-up actions within required timelines
- AS/BS in Biotechnology, Biology, Chemistry or equivalent
- Familiarity with ERP systems (Sage X3 or similar) and document management systems
- Good communication, leadership, and problem-solving skills
- Technical writing experience is a plus (e.g., SOPs, deviation reports, protocols)
Nice to have
- Oversee documentation-related workstreams (labels, EBR updates, media and materials requests), ensuring prioritization, accuracy, and on-time completion
- Ensure training records are current and audit-ready
- verify team compliance with required curricula, certifications, and role-based qualification plans
- Coordinate evaluation and implementation of new materials and equipment by defining user requirements, supporting trials, and confirming readiness for GMP use
- track progress and escalate unresolved items to leadership
- Coach employees on standard work and GMP expectations
- reinforce good practices through routine observations and feedback
- Coordinate with Training to schedule and complete required curricula
Visa & Work Authorization
- Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.