Quality Specialist
CSL, Shreveport, LA, United States
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, and federal requirements. This role will ensure compliance with training needs, SOPs, processes and other regulatory or company directives are adhered to in order to support the operations and quality requirements for business operations.
Responsibilities
Reporting compliance status data to operational quality management.
Collaborate with center management in the development and implementation of continuous improvement plans.
Collaborate with the Assistant Manager of Quality (AMQ) to represent the center during internal and external audits, respond to questions, and may stop operations, including shipments, to address quality concerns.
Coordinate and manage training activities, policies and processes at the center level.
Perform final QA review and release for all shipment and associated documents to ensure shipments meet customer specifications.
Ensure center records QA review is thorough, accurate, and timely; initiate investigations and document regulatory deficiencies; determine and document corrective actions and assess effectiveness.
Maintain and review center personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements.
Maintain the Learning Management System to ensure data integrity, report generation, and data analysis to comply with company and regulatory standards.
Initiate and coordinate schedules for delivery of all training, including new hire, annual, and retraining, ensuring the most current training materials are used.
Collaborate with center management to identify and deliver retraining for correcting or improving operational or quality issues.
Conduct periodic process assessments to ensure compliance with CSL written procedures, initiate investigations, and develop corrective action plans in partnership with management.
Identify and communicate non-conformities to CSL’s SOPs; in the absence of the AMQ, conduct monthly quality team meetings to inform, promote, assess, and identify opportunities for continuous process improvement in quality, safety, and training.
Promote Safety, Health and Environment Policies & Procedures; ensure safety training and practices are implemented and followed within the center.
Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA, and other regulations; develop center responses for deficiencies; host external audits conducted by regulatory agencies and customers when absent the AMQ.
Initiate, investigate, and close Trackwise reports in a timely manner; confirm through follow-up that corrective action was implemented and effective.
Maintain a clean, efficient work environment; comply with all HSE and OSHA policies and procedures; conduct routine internal procedure and documentation audits as applicable.
Follow all Standard Operating Procedures (SOPs), company policies and procedures.
Comply with all local, state, and federal regulations and laws, including ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.
Maintain confidentiality of all personnel, donor, and center information; understand policies related to hyperimmune programs at the center, if applicable.
Assist plasma center staff in completing other special projects or assignments as requested.
Perform other job-related duties as assigned.
Your Skills and Experience
Education
High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred.
Experience
Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.
Strong customer service skills.
Strong critical reasoning, decision-making, and problem-solving skills to analyze situations.
Organizational skills and attention to detail to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives.
Understand Quality Systems and/or regulated training requirements.
Working Conditions
Occasionally required to work with the public when they are dissatisfied.
80% standing and walking, 20% sitting.
Requires reaching, bending, kneeling, and high level of manual dexterity.
See and speak with customers and observe equipment operation.
Occasionally required to lift and carry 25 lbs.
Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please contact us for assistance.
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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, and federal requirements. This role will ensure compliance with training needs, SOPs, processes and other regulatory or company directives are adhered to in order to support the operations and quality requirements for business operations.
Responsibilities
Reporting compliance status data to operational quality management.
Collaborate with center management in the development and implementation of continuous improvement plans.
Collaborate with the Assistant Manager of Quality (AMQ) to represent the center during internal and external audits, respond to questions, and may stop operations, including shipments, to address quality concerns.
Coordinate and manage training activities, policies and processes at the center level.
Perform final QA review and release for all shipment and associated documents to ensure shipments meet customer specifications.
Ensure center records QA review is thorough, accurate, and timely; initiate investigations and document regulatory deficiencies; determine and document corrective actions and assess effectiveness.
Maintain and review center personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements.
Maintain the Learning Management System to ensure data integrity, report generation, and data analysis to comply with company and regulatory standards.
Initiate and coordinate schedules for delivery of all training, including new hire, annual, and retraining, ensuring the most current training materials are used.
Collaborate with center management to identify and deliver retraining for correcting or improving operational or quality issues.
Conduct periodic process assessments to ensure compliance with CSL written procedures, initiate investigations, and develop corrective action plans in partnership with management.
Identify and communicate non-conformities to CSL’s SOPs; in the absence of the AMQ, conduct monthly quality team meetings to inform, promote, assess, and identify opportunities for continuous process improvement in quality, safety, and training.
Promote Safety, Health and Environment Policies & Procedures; ensure safety training and practices are implemented and followed within the center.
Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA, and other regulations; develop center responses for deficiencies; host external audits conducted by regulatory agencies and customers when absent the AMQ.
Initiate, investigate, and close Trackwise reports in a timely manner; confirm through follow-up that corrective action was implemented and effective.
Maintain a clean, efficient work environment; comply with all HSE and OSHA policies and procedures; conduct routine internal procedure and documentation audits as applicable.
Follow all Standard Operating Procedures (SOPs), company policies and procedures.
Comply with all local, state, and federal regulations and laws, including ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.
Maintain confidentiality of all personnel, donor, and center information; understand policies related to hyperimmune programs at the center, if applicable.
Assist plasma center staff in completing other special projects or assignments as requested.
Perform other job-related duties as assigned.
Your Skills and Experience
Education
High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred.
Experience
Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.
Strong customer service skills.
Strong critical reasoning, decision-making, and problem-solving skills to analyze situations.
Organizational skills and attention to detail to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives.
Understand Quality Systems and/or regulated training requirements.
Working Conditions
Occasionally required to work with the public when they are dissatisfied.
80% standing and walking, 20% sitting.
Requires reaching, bending, kneeling, and high level of manual dexterity.
See and speak with customers and observe equipment operation.
Occasionally required to lift and carry 25 lbs.
Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please contact us for assistance.
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