Manufacturing Support Specialist 3

Key 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.
• Aid 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.

Minimum Qualifications

• Education/Training:
• AS/BS in Biotechnology, Biology, Chemistry, or a related field; a Science-related discipline is preferred.
• A High School Diploma or equivalent may be considered with relevant experience.
• Certification in aseptic techniques or GMP training is preferred.
• Experience:
• 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.
• Skills & Abilities:
• 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.

Other

• 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].

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 as required.