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The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements.
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Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements.
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This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements.
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Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOPs, CLIA/COLA and other applicable requirements. Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns.
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Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
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Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies.
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law.
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The position is in-office position, and immediate start date is required. Northmarq is seeking a Senior Communications Specialist to develop and execute internal and external communication initiatives that help drive business impact and bolster employee awareness and engagement.
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Associate or Bachelors degree in business administration or biological sciences preferred. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.
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Understand Quality Systems and/or regulated training requirements. Learn more about Diversity & Inclusion ( at CSL. Maintain confidentiality of all personnel, donor and center information. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.
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4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information.
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Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. Collaborate with center management in the development and implementation of continuous improvement plans.
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In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information.
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Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements.
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15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
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