Manufacturing Specialist – Cell Processing III
Winston Salem, NC, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Winston Salem, NC, US
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Manufacturing Specialist I - III – Cell Processing
Location: Winston Salem NC
Full time direct hire role
Hourly Pay Rates: $25-$34 depending on the level
The Manufacturing Specialists I-III, Cell Processing plays a key role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with industry guidelines. This role involves operating and maintaining production equipment, performing critical product freezing and storage, and driving continuous improvement. The Manufacturing Specialist III is also responsible for mentoring team members, leading investigations, and maintaining high levels of quality and compliance.
Essential Duties & Responsibilities:
- 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 ensure 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 to 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.
Secondary Responsibilities:
- Perform material qualification tests to qualify lots of incoming manufacturing material.
- Support process development and validation activities as needed.
- Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.
- Perform any other duties as assigned to support manufacturing operations effectively.
Minimum Qualifications:
- Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or a related field; a science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or equivalent may be considered with significant relevant experience.
- Experience: Preferred minimum of 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 2-3 years of proven expertise in a regulated environment.
- Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with industry regulations. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.
- Aseptic gowning and experience working in a cleanroom environment required
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