Department Specialist II
About The Position
Fractionation Manufacturing provides technical and operational support for the manufacturing processes involved in plasma fractionation. As a Department Specialist, you will ensure all fractionation operations comply with corporate policies, regulatory requirements (GMP, FDA, EMEA), and safety practices. The specialist works closely with cross-functional teams to ensure efficient, high-quality, and compliant production of plasma-derived products. How you will contribute: Prepare, maintain, and revise GMP (Good Manufacturing Practice) documentation and manufacturing records, including SOPs and job aids. Conduct training sessions for team members on general manufacturing processes and industry best practices. Proactively identify and help mitigate environmental, health, and safety (EHS) risks. Partner with Quality, Engineering, Maintenance, and Safety teams to drive process improvements and support CAPA implementation. Take part in root cause analyses, risk assessments, and continuous improvement initiatives using Lean and DMAIC methodologies. Contribute to site activities such as Gemba walks, audits, shutdowns, project implementations, and change control tasks. Support Tier board updates, 5S, Standard Work, and Business Excellence programs. Facilitate team meetings, training sessions, and cross-shift communication. Compile, analyze, and document project data, and develop presentations and supporting materials as needed. Ensure compliance with all regulatory requirements and internal standards within the manufacturing process. Follow established Quality Assurance protocols to uphold and improve quality standards. Standard work hours are 8:00 a.m. to 5:00 p.m., Monday through Friday.
Requirements
- Typically requires bachelor's degree in science, engineering or other related technical field.
- Some related experience preferred
- Professional (GMP industry) experience ideal
Responsibilities
- Prepare, maintain, and revise GMP (Good Manufacturing Practice) documentation and manufacturing records, including SOPs and job aids.
- Conduct training sessions for team members on general manufacturing processes and industry best practices.
- Proactively identify and help mitigate environmental, health, and safety (EHS) risks.
- Partner with Quality, Engineering, Maintenance, and Safety teams to drive process improvements and support CAPA implementation.
- Take part in root cause analyses, risk assessments, and continuous improvement initiatives using Lean and DMAIC methodologies.
- Contribute to site activities such as Gemba walks, audits, shutdowns, project implementations, and change control tasks.
- Support Tier board updates, 5S, Standard Work, and Business Excellence programs.
- Facilitate team meetings, training sessions, and cross-shift communication.
- Compile, analyze, and document project data, and develop presentations and supporting materials as needed.
- Ensure compliance with all regulatory requirements and internal standards within the manufacturing process.
- Follow established Quality Assurance protocols to uphold and improve quality standards.
Benefits
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
