ProKidney
Manufacturing Support Specialist II (Contract)
ProKidney, Winston Salem, North Carolina, United States, 27104
Manufacturing Support Specialist II (Contract)
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. Participate in material kit preparation. Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment. Ensure proper documentation of cleaning and maintenance activities. Support the maintenance of the clean room environment. Documentation & Compliance: Review, revise, and update SOPs, batch records, and other manufacturing documents. Complete and ensure the accuracy of GMP documentation. Participate in internal and external audits. Monitor and support compliance with GMP standards. Training, Mentoring & Leadership: Mentor and train new and less experienced staff. Lead by example to foster a culture of compliance and quality. Assist in training initiatives. Support the continuous improvement of manufacturing processes. Material & Equipment Management: Conduct routine cycle counts in cleanrooms. Manage and execute routine transactions in the ERP system. Ensure proper handling, storage, and documentation of materials and equipment. Safety & Process Improvement: Promote and enforce adherence to safety policies. Identify deviations from SOPs and GMP standards. Assist in the implementation of Corrective and Preventive Actions. Support process optimization initiatives. Collaboration & Data Collection: Collaborate with cross-functional teams. Assist in data collection efforts. Provide insights and contribute to the development of new procedures. Secondary Responsibilities: Perform additional tasks as needed. Contribute to data analysis and reporting efforts. Qualifications: AS/BS in Biotechnology, Biology, Chemistry, or a related field. 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]. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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. Participate in material kit preparation. Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment. Ensure proper documentation of cleaning and maintenance activities. Support the maintenance of the clean room environment. Documentation & Compliance: Review, revise, and update SOPs, batch records, and other manufacturing documents. Complete and ensure the accuracy of GMP documentation. Participate in internal and external audits. Monitor and support compliance with GMP standards. Training, Mentoring & Leadership: Mentor and train new and less experienced staff. Lead by example to foster a culture of compliance and quality. Assist in training initiatives. Support the continuous improvement of manufacturing processes. Material & Equipment Management: Conduct routine cycle counts in cleanrooms. Manage and execute routine transactions in the ERP system. Ensure proper handling, storage, and documentation of materials and equipment. Safety & Process Improvement: Promote and enforce adherence to safety policies. Identify deviations from SOPs and GMP standards. Assist in the implementation of Corrective and Preventive Actions. Support process optimization initiatives. Collaboration & Data Collection: Collaborate with cross-functional teams. Assist in data collection efforts. Provide insights and contribute to the development of new procedures. Secondary Responsibilities: Perform additional tasks as needed. Contribute to data analysis and reporting efforts. Qualifications: AS/BS in Biotechnology, Biology, Chemistry, or a related field. 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]. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.