Mfg Cell Processing Specialist 2 in Winston-Salem, North Carolina at PROKIDNEY

Winston-Salem, North Carolina, United States

Position Title: Mfg Cell Processing Specialist 2

The Manufacturing Specialist 2 plays a crucial role in supporting manufacturing operations with a focus on aseptic processing and adherence to cGMP guidelines. This position involves participating in the aseptic processing of in-house solutions and patient processes, ensuring compliance with Standard Operating Procedures (SOPs) and maintaining high standards of GMP documentation.

Essential Duties & Responsibilities:

• Participate in aseptic processing of in-house solutions and patient processes according to cGMP guidelines.
• Read, understand, and follow Standard Operating Procedures (SOPs) for all assigned tasks.
• Assist in revising and updating SOPs, batch records, and other documents as required.
• Assist in training and mentoring new staff members on manufacturing processes and procedures.
• Set up and operate production equipment such as control rate freezers, orbital shakers, etc., ensuring proper operation and maintenance.
• Assist in deviation and Corrective and Preventive Action (CAPA) investigations, compiling data and information as needed.
• Complete GMP documentation accurately, including batch records, logbooks, forms, etc., according to Good Documentation Practices (GDP).
• Perform routine transactions within the ERP system, including material requisitions and production tracking.
• Support the maintenance of the clean room environment to ensure compliance with cleanliness standards and below alert level limits.
• Maintain knowledge of and comply with all pertinent safety policies, rules, and regulations.
• Ensure all team members comply with safety rules and regulations.
• Perform procedures according to written guidelines, recognizing and addressing deviations from accepted practices.
• Work with a high degree of accountability and reliability, following instructions and pre-established guidelines.

Secondary Responsibilities:

• Perform material qualification tests to qualify lots of incoming manufacturing material.
• Provide support for process development activities as needed.
• Assist with data collection efforts and compile data as directed.
• Perform any other duties as assigned to support manufacturing operations effectively.

Minimum Qualifications:

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; preference for a Science-related discipline. Relevant experience may be considered in lieu of formal education. High School Diploma or Equivalent may be considered with relevant experience.

• Experience: Preferred minimum 1+ years of relevant experience in biotechnology manufacturing or a related field.

• Skills/Abilities: Ability to exercise judgment within defined procedures, follow production schedules and SOPs, and understand the importance of compliance with cGMPs. Proficiency in aseptic gowning and effective teamwork are essential. Strong computer skills including Microsoft Office, along with organizational, record-keeping, and time management abilities, are necessary.

• Other: Good eye/hand coordination, excellent written and oral communication skills, a team-oriented approach, and a strong work ethic are critical for success in this role.

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.