Quality Specialist

Quality Specialist Temple, PA Job Details Full-time 18 hours ago Qualifications Quality control corrective actions Civil rights Biology Document review (document control) EHS Customer service Regulatory compliance Associate's degree in Business Administration Data analysis skills Compliance audits & assessments HIPAA Environmental compliance Data reporting Corrective and preventive actions (CAPA) GMP Mid-level Improving operational efficiency Compliance management implementation Bachelor's degree in business administration Bachelor's degree in biology High school diploma or GED Schedule management Quality assurance audits Decision making Quality improvement CLIA regulations Organizational skills Business Administration Overseeing audit functions LMS Training & development 1 year Clean workspace maintenance Business Associate's degree Leadership Overseeing training FDA regulations Equal Employment Opportunity (EEO) Health and safety training programs

Full Job Description Entity:

CSL Plasma Job Category:

Quality Job Family:

Plasma Center Job Type:

Full Time Location :

Temple, Pennsylvania, United States Employer Reference:

R-275829

Job Description 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. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. Reporting compliance status data to operational quality management Collaborate with center management in the development and implementation of continuous improvement plans 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 Responsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, 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. 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. Ensure the most current version of training materials at the center is being used Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 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. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (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 to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with 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.dd 4-6 key responsibilities of the job 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 details 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 (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied 80% of the time standing and walking and 20% of the time sitting Reach, bend, kneel and have high level of manual dexterity See and speak with customers and observe equipment operation Occasionally be required to lift and carry 25 lbs. Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors About CSL Plasma CSL Plasma operates one of the world's largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (

ASX:

CSL;

USOTC:

CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people. For more information about CSL Plasma visit, https://www.cslplasma.com/. Our Benefits For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more visit https:

//www.csl.com/careers/inclusion-and-belonging 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 visit https://www.csl.com/accessibility-statement.