Director, Component & QC Laboratory
About The Position
The Director, Component & QC Laboratory position is responsible for the operation and management of the cGMP blood component processing laboratory; ensuring that all products meet the safety, purity and potency requirements of the FDA, AABB and other regulatory agencies. Responsible for business continuity and optimizing manufacturing to meet inventory needs. This position is considered “essential” during severe weather or emergency operation events. Responsible for processing and production functions of Component manufacturing and quality control laboratories. Develops and implements SOPs and ensures compliance with regulations and cGMPs. Prepares, develops and monitors budget and maintains cost by implementing productivity and efficiency gains. Directs, mentors, trains and develops assigned staff ensuring all competencies are performed. Trouble shoots, investigates and resolves complex and technical problems associated with lab operations. Ensure that current good manufacturing practices are evident in all component manufacturing functions. Provide guidance and expertise to ensure proper error management and root cause analysis to minimize risk and waste. Promote the development and implementation of corrective/ preventative actions resulting from errors and audit findings. Create department goals that support the local and Enterprise strategic goals. Responsible for the department's annual budget, including tracking department revenues and expenses. Recommend and implement changes to improve business unit practices, processes, and efficiencies. Promote staff engagement and communication of organization goals and changes that impact the department. Facilitate standardization between divisions to align with Enterprise goals. Prepares various reports and track and trend departmental data points for assessing efficiencies and workflow. Participate and/or lead organizational committees and projects. Routinely collaborate and communicate with others in the organization and enterprise. Attends and participates in conferences and seminars. Remain current with industry practices. Any related duties as assigned. Exemplifies BBD’s Customer Service Mission and Core Values.
Requirements
- Bachelor’s Degree in Medical Laboratory Science, Biology, Chemistry, or other related science to meet CLIA moderate complexity requirements of a Technical Consultant (TC)
- 4 years experience in blood banking, component processing, experience in cGMP Biologics manufacturing operations and experience assuring compliance with safety and cGMP requirements while adhering to a biologics manufacturing schedule
- 3 years of leadership or supervisory experience
- Knowledge of AABB, FDA, OSHA, and regulations
- Working knowledge of Microsoft Suites
- Working knowledge of BECS
- Working Knowledge of Good Manufacturing Practices (cGMP)
Responsibilities
- Responsible for the operation and management of the cGMP blood component processing laboratory
- Ensuring that all products meet the safety, purity and potency requirements of the FDA, AABB and other regulatory agencies
- Responsible for business continuity and optimizing manufacturing to meet inventory needs
- Responsible for processing and production functions of Component manufacturing and quality control laboratories
- Develops and implements SOPs and ensures compliance with regulations and cGMPs
- Prepares, develops and monitors budget and maintains cost by implementing productivity and efficiency gains
- Directs, mentors, trains and develops assigned staff ensuring all competencies are performed
- Trouble shoots, investigates and resolves complex and technical problems associated with lab operations
- Ensure that current good manufacturing practices are evident in all component manufacturing functions
- Provide guidance and expertise to ensure proper error management and root cause analysis to minimize risk and waste
- Promote the development and implementation of corrective/ preventative actions resulting from errors and audit findings
- Create department goals that support the local and Enterprise strategic goals
- Responsible for the department's annual budget, including tracking department revenues and expenses
- Recommend and implement changes to improve business unit practices, processes, and efficiencies
- Promote staff engagement and communication of organization goals and changes that impact the department
- Facilitate standardization between divisions to align with Enterprise goals
- Prepares various reports and track and trend departmental data points for assessing efficiencies and workflow
- Participate and/or lead organizational committees and projects
- Routinely collaborate and communicate with others in the organization and enterprise
- Attends and participates in conferences and seminars
- Remain current with industry practices
- Any related duties as assigned
- Exemplifies BBD’s Customer Service Mission and Core Values
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What This Job Offers
Job Type
Full-time
Career Level
Director
