Senior QA Apheresis Auditor

Gaithersburg, MD, USA

Full-TimeDepends on ExperienceMid-LevelBachelors

Job Description

Welcome to AstraZeneca, where we are dedicated to improving the lives of patients through innovative pharmaceuticals. We are currently seeking a Senior QA Apheresis Auditor to join our team and ensure the quality and compliance of our apheresis programs. As a Senior QA Apheresis Auditor, you will play a critical role in maintaining the highest standards of quality and safety in our apheresis processes. With your expertise, attention to detail, and strong interpersonal skills, you will help us continue to deliver life-changing treatments to patients around the world. Are you ready to make a difference in people's lives? Join us at AstraZeneca and take the next step in your career.

Conduct regular audits of apheresis programs to ensure compliance with regulatory requirements and company standards.
Develop and maintain audit schedules and plans to assess the quality and safety of apheresis processes.
Collaborate with cross-functional teams to identify areas for improvement and implement corrective actions.
Review and approve apheresis-related documentation, including standard operating procedures and training materials.
Communicate audit findings and recommendations to management and stakeholders.
Stay updated on relevant regulations and industry trends related to apheresis and quality assurance.
Train and mentor junior QA auditors on apheresis processes and procedures.
Conduct risk assessments and develop risk mitigation strategies for apheresis programs.
Participate in internal and external audits and inspections.
Act as a subject matter expert on apheresis processes and quality assurance practices.
Collaborate with vendors and suppliers to ensure their compliance with quality and safety standards.
Lead investigations into quality incidents and implement corrective and preventive actions.
Ensure timely and accurate reporting of apheresis-related quality metrics.
Foster a culture of continuous improvement and quality excellence within the organization.
Represent the company in a professional manner and uphold our commitment to patient safety and well-being.

Where is this job?

This job is located at Gaithersburg, MD, USA

Job Qualifications

Extensive Knowledge And Experience In Quality Assurance And Apheresis Processes: The Ideal Candidate For This Role Should Have A Deep Understanding Of Quality Assurance Principles And Practices, As Well As A Strong Background In Apheresis Procedures. This Will Ensure That They Are Able To Effectively Audit And Evaluate The Quality Of Apheresis Processes Within The Company.
Strong Analytical And Problem-Solving Skills: As A Senior Qa Apheresis Auditor, The Candidate Will Be Responsible For Identifying And Addressing Any Quality Issues That May Arise During Apheresis Procedures. Therefore, They Should Possess Strong Analytical Skills And Be Able To Think Critically To Identify The Root Cause Of Issues And Develop Effective Solutions.
Excellent Communication And Interpersonal Skills: This Role Involves Working Closely With Various Departments And Teams Within The Company, As Well As External Stakeholders. The Candidate Should Have Excellent Communication Skills To Effectively Communicate Audit Findings And Recommendations, As Well As Build And Maintain Relationships With Colleagues And Stakeholders.
Attention To Detail And Strong Organizational Skills: A Senior Qa Apheresis Auditor Must Have A Keen Eye For Detail And Be Able To Meticulously Review And Analyze Data And Documentation. They Should Also Have Strong Organizational Skills To Manage Multiple Audits And Tasks Simultaneously.
Experience In Regulatory Compliance: Astrazeneca Is A Highly Regulated Company, And The Senior Qa Apheresis Auditor Will Be Responsible For Ensuring That All Apheresis Processes And Procedures Adhere To Regulatory Standards. Therefore, The Ideal Candidate Should Have Experience In Regulatory Compliance And Be Familiar With Relevant Guidelines And Regulations.

Required Skills

Documentation
Quality Assurance
Data Analysis
Attention to detail
Auditing
Root Cause Analysis
Compliance
Risk assessment
Training and Development
Problem-Solving
Apheresis Processes

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Senior QA Apheresis Auditor in Gaithersburg, MD, USA is between $80,000 and $100,000 per year. However, this can vary depending on factors such as experience, education, and specific job responsibilities. It is recommended to research the specific company and job description for a more accurate salary estimate.

Additional Information

AstraZeneca is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedFebruary 19th, 2024

Apply BeforeApril 11th, 2026

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