Under minimal direction, this position is responsible for review
of the quality systems and compliance in all areas of technical and
clinical operations. Participates in operational excellence and
other performance improvement initiatives. Oversees staff
participation in performance improvement initiatives to include
data and process analysis. Serves as a resource to operations on
DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs
and external regulations. Brings compliance issues to the attention
Assures quality customer service to all customers.
Maintains good attendance and punctuality per the absence
Provides effective leadership to achieve high levels of service
and product quality, financial results, and other criteria in
accordance with policies, goals, and objectives.
Hires, supervises, trains, develops, and evaluates performance
of assigned personnel. Identifies and effectively resolves
Conducts data and process analysis activities including in-depth
analysis of deviation and operational performance data. Evaluates
data for trends and opportunities for improvement and communicates
this to operations management.
Ensures deviation management reports are accurate and timely and
that events are coded correctly. Facilitates root cause analysis,
reviews and approves corrective action, and performs effectiveness
Participates in improvement initiatives and the use of
improvement tools and methodologies. Serves as an improvement
resource to operations.
Evaluates process change to include data collection and risk
identification. Assists with development of risk mitigation
Hosts external inspections. Assists in facilitating responses to
observations. Ensures corrective actions were implemented and
effective. Conducts risk assessments.
Supports the internal audit program and the performance of
process based audits. Assists operations in evaluating
observations, performing investigations, and conducting root cause
analysis, and the development of corrective action. Performs
follow-up on audit observations. Tracks responses, monitoring
implementation, and ensures effectiveness of corrective action.
Participates on the review team to evaluate nonconforming
products, materials, or test results and assesses impact on
external customers. Ensures required actions are implemented.
Facilitates recalls and market withdrawals.
Assists in oversight of clinical study or research
Coordinates staff review of documents to ensure processes are
within control (e.g., QC data, validations, proficiency
Participates in annual budget preparation and ensures adherence
to approved department budget.
Performs all other duties, at the discretion of management, as
Bachelor's degree required.
Certification as a Medical Technologist or Specialist in Blood
Banking (SBB) by a recognized certifying agency or RN licensure
Five years of related experience in a regulated industry
required. To include:
Two years of supervisory experience.
Three years of experience in quality, regulatory, and/or
Must possess the skills and abilities to successfully perform
all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Must have analytical, statistical, personal organization, and
problem solving skills.
Must have a participative management style, strong team
development, coaching skills, and the ability to lead and motivate
senior and executive-level managers.
Effective oral and written business communication skills.
Able to organize, prioritize, and execute a variable workload
and multiple priorities.
Must have proficient computer skills.
Ability to work independently preferred.
Skills in performance improvement; data analysis; GMPs, HCT/Ps,
and CLIA regs. preferred
Experience in a clinical setting (e.g., transfusion service,
apheresis, or cell therapy) preferred.
Our organization is an equal employment/affirmative action
employer. If you need accommodation for any part of the employment
process because of a medical condition or disability, please send
an e-mail email@example.com or call 1-844-220-2612
to let us know the nature of your request. A representative will
respond to accommodation requests within two business days. Please
note that this email/phone number is for medical/disability
accommodations only and any other inquiries will not receive a
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Our organization participates in E-Verify, for more
All candidates who receive a conditional written offer of
employment will be required to undergo a pre-employment drug test
in accordance with the Company's established guidelines.