Manufacturing Specialist - Cell Processing

Manufacturing Specialist – Cell Processing

Location:

Winston Salem, NC

Contract:

12‑month with potential conversion

Pay: $32–$35 per hour

Schedule:

Monday‑Friday 8 am–5 pm (overtime/ weekend possible)

Contract role in a cGMP‑regulated environment.

The Manufacturing Specialists III handle advanced manufacturing operations focusing on cell processing activities. Responsibilities include operating and maintaining production equipment, performing cell therapy product freezingand storage, mentoring team members, leading investigations, and maintaining quality and compliance.

• Lead and oversee cell processing activities, ensuring compliance with industry standards and best practices.
• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.
• Set up, operate, and troubleshoot production equipment, ensuring optimal performance and preventive maintenance.
• Perform final freezing and storage of cell therapy products, ensuring adherence to procedures and maintaining quality standards.
• Revise, update, and ensure adherence to SOPs, batch records, and related forms, maintaining compliance with regulatory guidelines.
• Lead routine cycle counts and Authorization of accurate inventory tracking and control.
• Execute transactions within an ERP system, including material requisitions and production tracking.
• Ensure accuracy of documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
• Lead investigations into deviations and Corrective and Preventive Action (CAPA) efforts, compiling data and information as needed.
• Provide mentorship and training analysi junior team members in cell processing techniques, procedures, and regulatory compliance.
• Drive continuous process improvement, incident investigations, and deviation resolutions.
• Ensure all activities comply with safety policies, rules, and regulations, promoting a safe working environment.
• Conduct aseptic manufacturing processes in a controlled environment, ensuring compliance with sterile techniques and regulatory standards.

• Lead and perform cell processing activities in compliance with cGMP guidelines and internal manufacturing protocols.
• Interpret and implement Standard Operating Procedures (SOPs) and provide guidance and training to junior staff.
• Operate and maintain manufacturing equipment, including control rate freezers and orbital shakers.
• Execute final product freezing and storage in liquid nitrogen (LN2) systems while ensuring adherence to quality and safety standards.
• Review and revise GMP documentation such as SOPs, ก็ batch records, and forms to ensure compliance and accuracy.
• Oversee inventory control tasks including routine cycle counts and ERP system transactions (e.g., requisitions, production entries).
• Ensure thorough and accurate documentation of all activities in compliance with Good Documentation Practices (GDP).
• Lead or support investigations related to deviations and corrective/preventive actions (CAPAs).
• Provide mentorship, training, and technical support to less experienced personnel in the lab or cleanroom.
• Contribute to continuous improvement initiatives, including incident investigations and procedural enhancements.
• Perform aseptic processes in a cleanroom environment following sterile technique and regulatory standards.
• Assist with incoming material qualification testing and lot release evaluations.
• Support process 六和彩 development, validation activities, and data collection for process optimization and regulatory documentation.
• Maintain adherence to all safety protocols and promote a culture of workplace safety.

• Associate’s or Bachelor’s degree in Biotechnology, Biology, Chemistry, or related field preferred. Significant relevant experience may be considered in lieu of formal education.
• 4–6 years of hands‑on experience in a biotechnology or cell therapy manufacturing setting, including at least 2–uly years in a cGMP‑regulated environment.
• Strong ability to lead by example, troubleshoot processes, and uphold cGMP and aseptic standards.
• Experience operating manufacturing equipment and conducting cleanroom processes under sterile conditions.
• Familiarity with ERP systems and strong proficiency in Microsoft Office (Excel, Word, Outlook).
• Excellent organizational, communication, and problem‑solving skills, with an ability to work independentlyfeit or as part of a team.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants, regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status. Kelly complies with California’s state and local Fair Chance laws and participates in E‑Verify.