Department Specialist II

Role Summary

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.

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.
• Standard work hours are 8:00 a.m. to 5:00 p.m., Monday through Friday.

Qualifications

• Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred
• Professional (GMP industry) experience ideal

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Willingness to work extended or off-hours as required to meet business needs.
• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Some Clean Room and cool/hot storage conditions.