Medical Laboratory Technologist III, Technical Specialist
3 weeks ago
Location: Norcross, GA, 30071
Duration: 12 Months
Pay rate: $58.89/hr. on w2
GENERAL PURPOSE OF JOB
Performs a variety of tasks and functions associated with the appropriate day-to-day operations of the Technical Specialist division within the Quality Laboratories.
Ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. Serve as secondary contact for Laboratory Services. This includes but 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Serves as Medical Technologist Technical Specialist to ensure the alignment of the labs with training, OJTs and SOPs.
Trains identified trainers in each laboratory.
Technical writer for SOPs, OJTs and documentation of training metrics for lab services.
Performs administrative tasks and duties, when applicable; including the required recording of test results according to department procedures, quality plans/device history records, and/or work instructions (manufacturing records) and assisting with review of generated records.
Assists in training, retraining, and competency assessment of employees.
Participates in the internal audit process.
Assists with special projects, (such as Surveys and Validations) and other duties as assigned.
Participates in Antisera Qualification duties as needed.
Performs department Technical Review of documents prepared in the laboratory.
Responsibilities:
Creates legible, complete, and accurate records according to procedure/work- instruction-defined protocols, time frames and according to Current Good Manufacturing Procedures (cGMPÂÂÂÂÂs).
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.
Able to work cross-functionally across departments.
Maintains department morale and employee motivation through recognition, and staff engagement.
Ensure adequate communication with Managers or staff (verbally or written).
Support implementation of metrics and drive the performance of the metrics.
Participate in the SOP review and revision process.
Understand Lean / Six sigma concepts or continuous improvement.
Bachelors degree in Science from an accredited institute
3 years of experience in Blood Banking
3 years of experience in a highly Regulated/GMP environment
Lean/ Six sigma and or continuous improvement environment experience (preferred)
Project management experience preferred
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