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Overview

The Laboratory Services Superisor 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.

Qualifications

Minimum Knowledge & Experience:

• Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience. Bachelor’s degree in Science discipline, required
• MT (ASCP) or equivalent, prefer SBB certification
• 5-7 years of experience in Blood Banking, preferred
• 3 years of experience in a highly regulated/GMP environment, preferred
• Lean Six Sigma and/or continuous improvement experience, preferred
• Ability to read, analyza and interpret the most complex documents. Ability to respond effectively to the highest level of inquires 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 relialibility 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.

Skills & Capabilities:

• Creates legible, complete, and accurate records according to procedure/work- instruction-defined protocols, time frames and according to Current Good Manufacturing Procedures (cGMP’s).
• Follows applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Chemical hazards and blood borne pathogens), applicable laboratory OSHA regulations with respect to chemical hazards, blood-borne pathogens, etc.
• Understands FDA and ISO standards applicable to the department and consequences of nonconformance.
• Understands source, composition and characteristics of products and associated chemical and biosafety hazards.
• Maintains a polite, helpful, and professional manner with employees within the department and outside of the department.