Assistant Manager of Quality
Company: CSL Plasma
Location: East Providence
Posted on: January 16, 2022
--- Ensure center is "inspection ready" at all times by managing
adherence to Standard Operating Procedures (SOPs), compliance
policies and the quality system, utilizing sound Quality
principles, self-inspection learnings, non-conformity discovery and
appropriate remediation. Prepare regular reports to center, area
and corporate quality management as to the state of quality and
systems at the center.
--- Manage site Quality Control program including but not limited
to calibrations management, monitoring of compliance to defined
processes e.g. sampling, competency checks, Key Performance
Indicators (KPIs), trending and analysis of KPIs, root cause and
failure mode impact assessment and change management.
--- Lead and develop direct reports ensuring they are competently
skilled to perform their QA roles. Lead by example; consistently
motivate staff through education to high levels of competency that
drive success in a dynamic and regulated environment. Upon proper
review with center and quality management, recruit, hire, conduct
performance reviews and enact corrective actions, up to and
--- Participate with management to develop programs and methods to
streamline center processes resulting in improved customer/donor
service, product yields and financial results while maintaining
compliance and quality.
--- Receive and provide feedback to staff on observations leading
to improved adherence to GMP standards. Report concerns or
deficiencies to area personnel and/or area management immediately.
Make recommendations for remedial actions to resolve audit
observations and other non-compliance issues of deficiencies.
--- Lead and function as the key quality representative for site
supplier, customer and regulatory audits. Lead center review of
findings, coordination of remediation (CAPA), if needed and
successful closure of timely audits. Utilize quality tools and
applications to facilitate understanding of issues and
--- Maintain clean efficient work environment and ensure sufficient
operating supplies and availability of forms, as needed. Comply
with all Health Safety and Environmental (HSE) and Occupational
Safety and Health Administration (OSHA) policies and procedures.
Conduct routine audits of internal procedures and documentation, as
necessary. Promote safety in all actions.
--- Adhere to all HR policies and practices through fair and
equitable treatment of all employees. Communicate effectively with
HR to ensure HR compliance and ensure center management is doing
--- Comply with all federal, state and local regulatory and company
policies and procedures.
--- Responsible for notification to the ADOQ for any event that
negatively affects the safety, quality, identity, purity or potency
of the product that results in pausing or disruption of business.
If necessary, notification must be elevated to any of the
following, Regional Director, Associate Director of QA, Divisional
Director or Director of Quality Systems and Assurance.
--- Maintain confidentiality of all personnel, donor and center
information. Understand policies and procedures associated with
hyper immune programs at the center if applicable.
--- Lead investigations and deviations to determine root cause,
correction/preventative actions and effectiveness checks. Monitor
CAPA's and effectiveness checks to ensure issues are resolved.
--- Perform other job-related duties as assigned.
--- Bachelor's Degree preferred
--- Equivalent combination of education and professional work
--- Minimum 1 year supervisory, leadership experience responsible
for overseeing the activities of others, OR
--- 1 year Quality experience (CSA/CSAb) required OR
--- Completion of CSL Plasma Leadership Development program
--- Maintain company Technical Training certification
--- Knowledge of ever-changing and complex government and industry
regulations, and ability to monitor compliance with these
--- Monitor and manage entire financial responsibility of the
--- Proficient in English
(physical & mental requirements)
--- Ability to make decisions which have significant impact on the
department's creditability, operations and services
--- Ability to formulate complex and comprehensive materials such
as authoritative reports of major scope and impact, etc. and/or to
make formal presentations
--- Frequently exposed to hazardous chemicals, extreme temperatures
and to blood borne pathogens
--- Overnight travel required up to 10% of the time
--- Generally spends 80% of the time standing and walking and 20%
of time sitting
--- Occasionally lift and carry up to 25 lbs.
--- Exposure to hot and cold temperatures, sudden temperature
changes working with freezers and various odors
--- Exposure to human source products and various chemicals
including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach,
germicide solution, etc.
--- Required to wear Personal Protective Equipment while performing
specific tasks or in certain areas
--- Fast paced environment with frequent interruptions
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.
--- Bachelor degree in scientific discipline/life sciences or
--- 5+ years' experience related to quality and regulatory/ Plasma
--- Demonstrated leadership/supervisory experience
--- Knowledge of government and industry regulations
We 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 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 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 Plasma, East Providence , Assistant Manager of Quality, Executive , East Providence, Rhode Island
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