ProKidney

Mfg Support Specialist 3

Winston-Salem, North Carolina, United States · Senior

Work authorization requiredDetected 26 days ago

Data AnalysisProcess ImprovementERPGMPLeadershipCollaborationTime ManagementMentoringMicrosoft Office

About the role

This position requires a high level of expertise in performing complex aseptic processing of in-house solutions, preparing materials and kits, managing GMP areas, and ensuring stringent compliance with Standard Operating Procedures (SOPs).

Perform aseptic processing of in-house solutions according to current cGMP guidelines, ensuring all processes maintain the highest standards of sterility and quality.
Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment following approved cleaning procedures and industry best practices.
Support the maintenance of the clean room environment, ensuring it remains below alert level limits and is consistently compliant with cleanliness standards.
Review, revise, and update SOPs, batch records, and other manufacturing documents to maintain compliance with current regulatory requirements and best practices.
Monitor and support compliance with GMP standards and assist with deviation investigations, ensuring corrective actions are implemented where necessary.
Lead by example to foster a culture of compliance and quality, ensuring all team members follow established guidelines and safety regulations.
Support the continuous improvement of manufacturing processes and SOPs through participation in cross-functional meetings and projects.
Manage and execute routine transactions in the ERP system, including material requisitions, production tracking, and inventory management.
Ensure proper handling, storage, and documentation of materials and equipment to prevent contamination and maintain compliance with GMP standards.
Support process optimization initiatives and work with teams to improve operational efficiencies while maintaining regulatory compliance.

Proficiency in aseptic gowning, aseptic processing, and performing in a team-oriented environment.

AS/BS in Biotechnology, Biology, Chemistry, or a related field
a Science-related discipline is preferred.
High School Diploma or equivalent may be considered with relevant experience.
Certification in aseptic techniques or GMP training is preferred.
2-4 years of relevant experience in biotechnology manufacturing, GMP environments, or a related field.
Demonstrated experience with aseptic techniques, GMP cleaning, and working in a regulated environment.
Experience with SOP revision, documentation control, and deviation/CAPA investigations is preferred.

Strong knowledge of cGMP and GDP standards, with the ability to follow production schedules and SOPs.
Strong computer skills, including proficiency in Microsoft Office, ERP systems, and other relevant software tools.
Excellent organizational, record-keeping, and time management abilities.
Ability to exercise independent judgment, solve problems, and identify improvements.
Assist in data collection efforts for troubleshooting, CAPA investigations, and other manufacturing-related tasks.
Provide insights and contribute to the development of new procedures, technologies, and improvements within manufacturing operations.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

This listing is sourced directly from ProKidney's careers page and normalized into a canonical job model.