Lead the daily operations within the lab, managing workflows, coordinating staff schedules, and overseeing project activities in collaboration with the department manager.
Support the Lab Management Team by upholding safety standards, adhering to quality practices, and ensuring compliance with regulatory requirements such as cGMP, FDA, AABB, and other relevant guidelines.
Responsibilities
Ensure compliance with current good manufacturing practices (cGMP) and applicable regulatory requirements.
Oversee the movement and processing of samples, blood products, and components within the department, ensuring smooth operations between different lab areas.
Adjust staff assignments as necessary to meet departmental needs and support overall operations.
Maintain effective communication across lab areas to ensure high service levels.
Contribute to the development and review of departmental policies and procedures.
Review daily records and reports, taking necessary actions based on data analysis.
Manage temperature monitoring systems and resolve equipment-related issues.
Assist in performance evaluations, staff development, and training.
Conduct employee counseling, coaching, and disciplinary actions as needed.
Collaborate with management on drafting and revising controlled documents.
Participate in equipment validation, re-qualification, and new software implementation.
Keep management informed of potential issues affecting department operations.
Finalize quality investigations, evaluations, CAPA processes, and reviews for error events.
Supervise the Quality & Development (Q&D) process for the lab.
Assist with department meetings and attend other relevant meetings as required.
Promote professional growth and development for both staff and self.
Comply with affirmative action policies and perform additional duties as needed.
Qualifications
Minimum of 2 years of experience in blood banking, including leadership and possibly IRL experience.
Advanced knowledge of blood banking, laboratory operations, component manufacturing, and cGMP regulations.
Proficient in regulatory standards (FDA, AABB, OSHA, etc.).
Highly detail-oriented, organized, and capable of managing multiple priorities with flexibility and self-motivation.
Strong problem-solving abilities for technical challenges and workflow management.
Excellent interpersonal and communication skills, with the ability to maintain confidentiality and integrity.
Ability to work under pressure, manage change, and make sound decisions with accountability.
Willingness to work flexible hours or attend meetings outside of normal schedules as needed.
