Senior Quality Assurance Specialist- QA Validation & Tech Support

Holly Springs, NC, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Welcome to Amgen! We are currently seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team as a QA Validation & Tech Support specialist. In this role, you will play a crucial part in ensuring the quality and compliance of our products through the validation of processes, systems, and equipment. You will also provide technical support to our manufacturing and quality control teams, ensuring that our products meet regulatory standards. The ideal candidate will have a strong background in quality assurance and a thorough understanding of validation principles. If you are a detail-oriented, collaborative, and results-driven individual with a passion for ensuring product quality, we would love to have you on our team. Read on to learn more about the qualifications and responsibilities for this exciting opportunity.

Develop and execute validation strategies for processes, systems, and equipment in accordance with regulatory requirements and Amgen's quality standards.
Collaborate with cross-functional teams to ensure that validation activities are completed in a timely and efficient manner.
Conduct risk assessments and develop risk mitigation plans to ensure the quality and reliability of products.
Review and approve validation protocols, reports, and other documentation to ensure accuracy and completeness.
Provide technical support to manufacturing and quality control teams, including troubleshooting issues and implementing corrective actions.
Monitor and analyze data from validation activities to identify trends and potential areas for improvement.
Stay up-to-date on industry trends, regulations, and best practices related to validation to ensure compliance with global standards.
Participate in internal and external audits to ensure compliance with regulatory requirements and Amgen's quality standards.
Collaborate with suppliers and contractors to ensure the validation of external processes and equipment used in the production of Amgen products.
Train and mentor junior QA team members on validation principles and procedures.
Communicate effectively with all levels of the organization, including presenting validation data and reports to senior management.
Maintain accurate and organized documentation of all validation activities in accordance with Amgen's quality standards.
Continuously identify opportunities for process improvement and implement solutions to enhance the efficiency and effectiveness of validation activities.
Adhere to all safety protocols and procedures to ensure a safe working environment for all employees.
Act as a subject matter expert on validation principles and procedures, providing guidance and support to other departments as needed.

Where is this job?

This job is located at Holly Springs, NC, USA

Job Qualifications

Extensive Experience In Quality Assurance And Validation: The Ideal Candidate For This Role Should Have At Least 7 Years Of Experience In Quality Assurance And Validation, Preferably In The Pharmaceutical Industry. They Should Be Well-Versed In Current Industry Standards And Regulations, As Well As Have A Strong Understanding Of Quality Control Processes.
Proficiency In Technical Support: The Senior Quality Assurance Specialist Will Be Responsible For Providing Technical Support To Various Departments Within Amgen. Therefore, They Should Have A Strong Technical Background And Be Proficient In Troubleshooting And Resolving Technical Issues.
Strong Analytical And Problem-Solving Skills: As A Qa Validation & Tech Support Specialist, The Candidate Should Possess Strong Analytical And Problem-Solving Skills To Identify And Resolve Quality-Related Issues Efficiently. They Should Be Able To Conduct Root Cause Analysis And Implement Corrective And Preventive Actions To Ensure Compliance And Improve Processes.
Excellent Communication And Interpersonal Skills: This Role Will Require Frequent Interaction With Cross-Functional Teams, Including Manufacturing, Research And Development, And Regulatory Affairs. Hence, The Candidate Should Have Excellent Communication And Interpersonal Skills To Effectively Convey Technical Information And Collaborate With Different Stakeholders.
Attention To Detail And Ability To Work Independently: The Candidate Should Have A Keen Eye For Detail And Be Able To Work Independently To Manage And Prioritize Multiple Tasks Effectively. They Should Also Have A Thorough Understanding Of Quality Management Systems And Be Able To Work Within Strict Timelines To Ensure Compliance With Industry Standards.

Required Skills

Process Improvement
Project Management
Data Analysis
Technical Support
Quality Control
Compliance Management
Risk assessment
Documentation management
Root cause
Audit Preparation
Testing Protocols
Validation Processes

Soft Skills

Communication
Emotional Intelligence
Leadership
Time management
creativity
Organization
flexibility
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Senior Quality Assurance Specialist- QA Validation & Tech Support in Holly Springs, NC, USA is $85,000-$110,000 per year. This may vary depending on factors such as years of experience, education level, and specific skills and qualifications.

Additional Information

Amgen 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 PostedAugust 13th, 2024

Apply BeforeMay 22nd, 2025

This job posting is from a verified source.

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