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Quality Specialist

Quality Specialist
US-RI, East Providence 202, CSL Plasma
Job ID : R-040260
Job ID : R-040260

This position should not 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. In this role, an employee would not routinely be involved in manufacturing activities and must be independent from production with no additional operational responsibilities. The focus is to 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

1 In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect.
2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.
3 Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor.
4 May educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally.
5 Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff.
6 Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.
7 Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues.
8 Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service.
9 Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader of Supervisor of donor flow issues.
10 Collects arm samples or whole blood samples from donors for testing.
11 Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs).
12 Understands the policies and procedures associated with hyper immune programs at the center if applicable.
13 Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions.
14 Maintains confidentiality of all personnel, donor and center information.
15 May be cross-trained in other areas to meet the needs of the business.
16 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
17 Perform other job-related duties as assigned.

Education
• High school diploma or equivalent required.

Experience
• Minimum twelve (12) months experience in a medical or health care environment preferred or equivalent combination of education and experience.

Working Conditions
(physical & mental requirements)
• Ability to complete routine forms or conduct routine oral communications
• Ability to understand, remember and apply oral and/or written instructions
• Must be able to see and speak with customers and observe equipment operation.
• Occasionally perform tasks while standing and walking up to 100% of time
• Reach, bend, kneel and have high level of manual dexterity
• Occasionally be required to lift and carry up to 25 pounds
• Fast paced environment with frequent interruptions
• Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens.
• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
• Required to work overtime and extended hours to support center operational needs


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.

Worker Type:

Employee

Worker Sub Type:

Regular

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