Quality Specialist
Company: CSL Behring
Location: Westland
Posted on: January 12, 2021
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Job Description:
About CSL With 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 Description 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 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 Behring, Westland , Quality Specialist, Other , Westland, Michigan
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