Position Summary:

The Manufacturing Support Specialist II plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines. 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). The role also involves actively participating in document revision, providing training and mentoring to junior staff, and assisting in deviation and CAPA (Corrective and Preventive Action) investigations. As a senior position, the Specialist II will be a key contributor to maintaining high standards of GMP documentation and will work with a high degree of accountability and independence to ensure the continuous improvement of manufacturing operations.

Please note: This is a contract position which will not include ProKidney benefits.

Responsibilities:

Aseptic Processing & GMP Maintenance:

• Perform aseptic processing of in-house solutions according to current cGMP guidelines, ensuring all processes maintain the highest standards of sterility and quality.
• Participate in material kit preparation, ensuring alignment with Good Documentation Practices (GDP) and cGMP standards.
• Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment following approved cleaning procedures and industry best practices.
• Ensure proper documentation of cleaning and maintenance activities, including batch records and logbooks, in strict adherence to GMP and GDP standards.
• Support the maintenance of the clean room environment, ensuring it remains below alert level limits and is consistently compliant with cleanliness standards.

Documentation & Compliance:

• Review, revise, and update SOPs, batch records, and other manufacturing documents to maintain compliance with current regulatory requirements and best practices.
• Complete and ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, in compliance with GDP.
• Participate in internal and external audits, supporting the team in ensuring compliance with regulatory bodies, including the FDA.
• Monitor and support compliance with GMP standards and assist with deviation investigations, ensuring corrective actions are implemented where necessary.

Training, Mentoring & Leadership:

• Mentor and train new and less experienced staff on manufacturing processes, GMP procedures, and safety protocols.
• Lead by example to foster a culture of compliance and quality, ensuring all team members follow established guidelines and safety regulations.
• Assist in training initiatives for the broader team, focusing on aseptic techniques, GMP best practices, and proper documentation practices.
• Support the continuous improvement of manufacturing processes and SOPs through participation in cross-functional meetings and projects.

Material & Equipment Management:

• Conduct routine cycle counts in cleanrooms to ensure accurate inventory levels and prevent shortages.
• 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.

Safety & Process Improvement:

• Promote and enforce adherence to safety policies and procedures to prevent workplace accidents and injuries.
• Proactively identify deviations from SOPs and GMP standards and take immediate corrective action.
• Assist in the implementation of Corrective and Preventive Actions (CAPAs), identifying root causes of issues and ensuring solutions are effectively put in place.
• Support process optimization initiatives and work with teams to improve operational efficiencies while maintaining regulatory compliance.

Collaboration & Data Collection:

• Collaborate with cross-functional teams, including production, quality assurance, and engineering, to ensure seamless operations and continuous adherence to manufacturing standards.
• 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.

Secondary Responsibilities:

• Perform additional tasks as needed to support the manufacturing team and ensure the smooth operation of the manufacturing process.
• Contribute to data analysis and reporting efforts as directed.

Qualifications:

• 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+ 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.
• Proficiency in aseptic gowning, aseptic processing, and performing in a team-oriented environment.
• High level of attention to detail and the ability to manage multiple tasks and priorities effectively.
• 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 communicate effectively, both written and verbally, with a diverse team and in cross-functional environments.
• Ability to exercise independent judgment, solve problems, and identify improvements.
• Strong eye/hand coordination and commitment to maintaining a high quality of work.
• A leadership mindset with the ability to mentor and train others.
• Willingness to wear protective clothing and equipment as required in a GMP environment.
• Ability to lift and move objects up to [specific weight, e.g., 25 pounds].