Quality Specialist
Company: CSL Behring
Location: Wichita
Posted on: January 23, 2023
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Job Description:
Job DescriptionJob 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
used7 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.About UsOur BenefitsWe encourage you to
make your well-being a priority. It's important and so are you.
Learn more about how we care at CSL.About CSL PlasmaCSL 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 usAs a global organisation with employees
in 35+ countries, CSL embraces diversity, equity and inclusion.
Learn more about Diversity, Equity & Inclusion at CSL.Do work that
matters at CSL Plasma!
Keywords: CSL Behring, Wichita , Quality Specialist, Other , Wichita, Kansas
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