Manager, Component Laboratory
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Skills
About the role
Responsibilities
Manager, Component Laboratory
Blood Bank of Delmarva
Christiana Donor Center/Headquarters - Newark, DE
Join our life saving mission!
***Full Benefits***
The Manager, Component Laboratory position is responsible for managing the operation and staffing of the blood component processing laboratory, which includes blood product QC testing; ensuring that all products meet cGMP, the safety, purity, and potency requirements of the FDA, AABB, and other regulatory agencies.
Manages, trains, mentors, and develops assigned staff.
Ensures adherence to SOPs, regulations, guidelines, practices and policies.
Creating and revising SOPs and other controlled documents.
Write and manage validation, verification, and qualification protocols.
Plans and directs the processing and production functions of the laboratory in order to meet goals.
Ensure appropriate staff scheduling to meet business needs.
Maintains documentation associated with receiving processing and labeling of blood components.
Troubleshoots and resolves technical problems and investigates and corrects errors.
Assists in preparing, developing, and monitoring annual budget for each cost center and analyzes and explains any variances.
Manage deviations by investigating, ensuring appropriate corrective and preventive actions are complete, and documenting findings and actions in MasterControl.
Perform periodic reviews and changes of departmental controlled documents.
Assist in coordinating department response to audit findings and other CAPAs.
Assist in the development of new products, as requested by hospitals, in accordance with FDA regulations.
Ensure that product quality control is performed and acceptable. Resolve any problems associated with quality control.
Ensure that equipment maintenance is performed according to predetermined schedule.
Assist with new computer software, equipment or test method validation, as required.
Prepare various reports and track and trend departmental data points for assessing efficiencies and workflow.
Participate and/or lead organizational committees and projects.
Make recommendations to improve business unit practices and processes.
Collaborate and communicate with others in the organization and enterprise.
Attend trainings and remain current on industry information.
Any related duties as assigned.
Qualifications
Education:
Bachelor’s Degree in Biological Science or related field, preferred.
Experience:
5 years of Blood Bank, Medical, or Production/Manufacturing experience.
2 years leading or supervising a team of staff in a similar environment.
Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.
Overview
Founded in 1954, Blood Bank of Delmarva (BBD) has served the Delmarva Peninsula for over 70 years, delivering nearly 100,000 lifesaving blood products annually to 45+ hospitals, EMS and healthcare partners. BBD is part of New York Blood Center Enterprises (NYBCe), which operates in 16 states and delivers one million blood products to nearly 550 U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. BBD serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit delmarvablood.org. Connect with us on Facebook, X, Instagram, and LinkedIn.
NYBCe is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disabled status, or genetic information.