Quality Specialist
Company: CSL Plasma
Location: Topeka
Posted on: November 14, 2023
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Job Description:
Job Description Summary 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 Job Description 1 Perform final QA
review and release for all shipment and associated documents, to
ensure shipment meets customer specifications. 2 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. 3 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. 4 Maintain and review Plasma center personnel training
documents to ensure documents comply with CSL procedures, SOP's,
CLIA/COLA and other applicable requirements. 5 Maintain the
Learning Management System to ensure data integrity, report
generation and data analysis to comply with company and regulatory
standards. 6 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 7 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. 8 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. 9 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. 10 Promote Safety, Health and Environment
Policies & Procedure. Ensure safety training and safety practices
are implemented and followed within the center. 11 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. 12 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. 13 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. 14 Follow all Standard
Operating Procedures (SOPs), company policies and procedures. 15
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. 16 Maintain confidentiality of all personnel,
donor and center information. Understand policies and procedures
associated with hyperimmune programs at the center, if applicable.
17 Assist Plasma center staff in completing other special projects
or assignments, as requested. 18 Perform other job-related duties,
as assigned. 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 requirementsWorking 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 odorsAll
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.
CSL offers the following benefits for this full-time position, most
are effective the first day of hire: Options for health care
benefits, including choices of plans for medical and prescription
drug, dental, and vision 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.
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. For more information on CSL Plasma
benefits visit . About CSL Plasma 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!
Keywords: CSL Plasma, Topeka , Quality Specialist, Other , Topeka, Kansas
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