Supervisor, Laboratory Services - Transfusion

Werfen•Norcross, GA

9h•Onsite

About The Position

The Laboratory Services Supervisor performs a variety of tasks and functions associated with the appropriate day-to-day operations of the Quality Laboratories and supervises the performance of a variety of tasks within the division. Ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. Serve as main point of contact for Laboratory Services. This includes but is not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, serological duties, chemistries and any other task associated with making sure the products reach the customers. Assist with review and approving of test data, preparing validation documents, writing, reviewing and creating SOPs and OJTs. Overseeing and assisting with special projects.

Requirements

Bachelor's degree (BS/BA) from a four-year college or university; or equivalent combination of education and experience.
Bachelor’s degree in a Science discipline.
Ability to read, analyze and interpret the most complex documents.
Ability to respond effectively to the highest level of inquiries or complaints.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of tests reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases.
Ability to deal with a variety of abstract and concrete variables.

Nice To Haves

MT (ASCP) or equivalent certification
SBB certification
5-7 years of experience in Blood Banking
3 years of experience in a highly regulated/GMP environment
Lean Six Sigma and/or continuous improvement experience

Responsibilities

Perform a variety of tasks and functions associated with the appropriate day-to-day operations of the Quality Laboratories.
Supervise the performance of a variety of tasks within the division.
Ensure a strong GMP environment within a dynamic manufacturing/quality environment.
Achieve compliance ready state of each laboratory area.
Serve as the main point of contact for Laboratory Services.
Coordinate training for new and incumbent employees on equipment, documentation, product control, product handling, storage, serological duties, chemistries, and other tasks.
Assist with reviewing and approving test data.
Assist with preparing validation documents.
Assist with writing, reviewing, and creating SOPs and OJTs.
Oversee and assist with special projects.
Create legible, complete, and accurate records according to procedure/work-instruction-defined protocols, time frames, and according to Current Good Manufacturing Procedures (cGMP’s).
Follow applicable laboratory SOPs, OSHA regulations, and cGMP regulations (i.e. Chemical hazards and blood borne pathogens).
Understand FDA and ISO standards applicable to the department and consequences of nonconformance.
Understand the source, composition, and characteristics of products and associated chemical and biosafety hazards.
Maintain a polite, helpful, and professional manner with employees within and outside of the department.