Quality Specialist

Quality Specialist

This position provides immediate support to the Assistant Manager 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 Quality Manager (AQM), 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

Reports To:

Assistant Manager of Quality or Quality Manager

Direct Reports:

This position does not have any direct reports

RESPONSIBILITIES

1Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.

2Ensure 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.

3Perform 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.

4Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOPs, CLIA/COLA and other applicable requirements.

5Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.

6Initiates 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

7Collaborates 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.

8Conduct 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.

9Identifying and communicate non-conformities to CSLs SOPs. 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.

10Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.

11Conducts 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.

12Responsible to initiate, investigate and close Deviation reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.

13Maintain clean efficient work environment. Comply with all Environmental Health & Safety (EHS) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.

14Follow all Standard Operating Procedures (SOPs), company policies and procedures.

15Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.

16Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.

17Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.

18Assist Plasma center staff in completing other special projects or assignments, as requested.

19Perform other job-related duties, as assigned.

JOB SPECIFICATIONS

Provide minimum hiring requirements, specialized knowledge, and other considerations required

Education

• High School diploma or equivalency required
• Associate or Bachelors 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

Additional Comments

• Minimum travel required
• Bilingual skills preferred, at the discretion of the organization to meet the needs of the business. This could be Spanish, French, Russian or other non-English languages
• Work in a fast paced, dynamic environment
• Learn new processes and quickly engage in assignments to drive for action
• Attention to detail and ability to follow written and verbal directions in exact detail required
• Frequently required to make and accept modifications to working processes and procedure per SOP
• Make decisions in accordance with established policies and procedures
• Exercise independent and good judgment to refer decisions when decisions fall out to the realm of established guidelines
• Lead teams without the benefit of a direct reporting relationship
• Maintain technical competencies in all areas

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
• Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc.
• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
• Work in fast paced environment with frequent interruptions

Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.

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 CSLs 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. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.

About CSLPlasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Plasma!