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Scantibodies Biologics Plasma Center, located in El Cajon, CA is currently seeking a Quality Assurance Specialist.
The Quality Assurance Specialist is responsible for monitoring donor center processes to ensure compliance with Scantibodies Biologics, Inc. Standard Operating Procedures, as well as all applicable State, Federal, or International regulatory requirements. Reports compliance status to Operational and Regulatory Compliance management. Participates, with Center management, in the development and implementation of continuous improvement plans. Represents the Center during internal and external audits, and responds to questions. May stop operations, including shipments, to address quality concerns.
Essential Duties include:
Quality Assurance audits
Release of Plasma shipments
Release of Softgoods supplies
Inspection Management of internal/external audits
CLIA and Safety Committees
High school diploma or equivalent required. Associates degree preferred or equivalent formal Medical, Laboratory, or Manufacturing certification or license. Minimum of four years related experience, will consider experience in lieu of education requirements.
Strong attention to detail is required, able to utilize standard office equipment and perform basic mathematical functions, and able to work independently with limited supervision. Proficient with PC in office applications software including Word and Excel programs.
Good customer service skills is needed.
Must maintain knowledge of state, federal and Company policies and procedures to maintain job requirements.
The following job functions are important for success:
Working Conditions/Physical & Mental Demands:
Environmentally controlled office and lab areas of donor center. Required to enter an environment with a temperature of -30 C for short periods of time.
Ability to sit or stand for extended periods for up to four hours at a time.
Occupational exposure to blood borne pathogens.
Strong verbal and written communication skills, communicating with various levels of employees, as well as possible presentations from time to time.
Supervision of Others:
SBI is an equal opportunity employer and all employees are responsible for maintaining a discrimination and harassment free environment.
All employees are accountable for conducting their daily business responsibilities in an ethical and moral manner.
The above declarations are not intended to be an all-inclusive list of duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are intended only to describe the general nature of the job.