Quality Specialist
Company: CSL Plasma
Location: Champaign
Posted on: January 12, 2021
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Job Description:
About CSLWith operations in 35+ nations and -27,000 employees
worldwide, CSL is driven to develop and deliver a broad range of
lifesaving therapies to treat disorders such as hemophilia and
primary immune deficiencies, and vaccines to prevent influenza. Our
therapies are also used in cardiac surgery, organ transplantation
and burn treatment.CSL is the parent company of CSL Behring and
Seqirus. CSL Behring is a global leader in the protein
biotherapeutics industry, focused on bringing to market
biotherapies used to treat serious and often rare conditions. CSL
Behring operates CSL Plasma, one of the world's largest collectors
of human plasma, which is used to create CSL's therapies. Seqirus
is one of the largest influenza vaccine companies in the world and
is a transcontinental partner in pandemic preparedness and a major
contributor to the prevention and control of influenza globally.We
invite you to take a look at the many career possibilities
available around the globe and consider building your promising
future at CSL by becoming a member of our team!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 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 requirements
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 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. #CB #CB
Keywords: CSL Plasma, Champaign , Quality Specialist, Other , Champaign, Illinois
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