Quality Specialist

Quality Assurance Manager

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

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

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

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

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

Our Benefits

CSL offers the following benefits for this full-time position : Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.

About CSL Plasma

CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.

We want CSL to reflect the world around us

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.

Do work that matters at CSL Plasma!

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. 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.