SunCoast Blood Centers needs to ensure the safe, compliant, and efficient processing of lifesaving blood components through effective management of its Product Manufacturing Department, adhering to strict regulatory standards and organizational SOPs.
Requirements
- In-depth understanding of FDA, AABB, cGMP, and related regulatory requirements.
- Competence in automated systems and laboratory information management systems (LIMS).
- Ability to train, mentor, and develop technical staff.
- Demonstrated ability to manage multiple priorities in a regulated environment.
- Strong analytical and problem-solving skills.
- High attention to detail and commitment to quality.
- Manual dexterity for laboratory and computer-based work.
Responsibilities
- Oversee the development, review, and maintenance of department SOPs.
- Write and execute validations prior to implementing new processes, equipment, or software.
- Determine and monitor required sample size for monthly Quality Control (QC) testing.
- Assist with the development, performance, and scheduling of product QC activities.
- Oversee the resolution of any discrepancies or product holds related to QC.
- Collaborate with QA and laboratory teams to ensure integrity of product data and labeling accuracy.
- Ensure accurate completion of production and test result documentation.
Other
- Serve as a working supervisor for the Product Manufacturing Department, ensuring all activities comply with SOPs and regulatory guidelines.
- Supervise, train, coach, and evaluate staff to maintain a high-functioning, compliant team.
- Prepare and manage departmental work schedules and ensure proper coverage.
- Interview and recommend qualified candidates for Product Manufacturing positions.
- Minimum of five years of experience in blood banking, component manufacturing, or laboratory operations, with at least two years in a leadership or supervisory role.
