Welcome to Amgen, a leading biotechnology company dedicated to discovering, developing, and delivering innovative medicines to patients worldwide. We are currently seeking a highly motivated and experienced individual to join our team as a Senior Associate Plant Quality Assurance. This role is a vital part of our Quality Assurance team, ensuring that our manufacturing processes meet the highest standards of quality and compliance. If you are passionate about making a difference in the lives of patients and have a strong background in quality assurance, we encourage you to apply.
- Conduct Quality Assurance activities in accordance with Amgen's policies, procedures, and regulatory requirements.
- Monitor and evaluate the quality of manufacturing processes and products, identifying any potential issues or deviations.
- Develop and implement quality control systems and procedures to ensure compliance with industry standards and regulations.
- Collaborate with cross-functional teams to identify areas for improvement and develop solutions to enhance product quality and efficiency.
- Perform regular audits and inspections of manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP).
- Review and approve manufacturing documentation, including batch records, protocols, and reports.
- Investigate and document any quality incidents or deviations, identifying root causes and implementing corrective and preventative actions.
- Communicate with external stakeholders, including regulatory agencies, to ensure compliance with regulations and resolve any quality issues.
- Train and mentor junior team members on quality assurance processes and procedures.
- Stay up-to-date with industry trends and developments in quality assurance to continuously improve processes and procedures.
- Uphold Amgen's commitment to patient safety and product quality in all aspects of job responsibilities.
Bachelor's Degree In A Relevant Scientific Field, Such As Biology, Chemistry, Or Pharmaceutical Sciences.
Minimum Of 5 Years Of Experience In A Quality Assurance Role Within The Biotechnology Or Pharmaceutical Industry.
Knowledge And Understanding Of Current Good Manufacturing Practices (Cgmp) And Regulatory Requirements.
Strong Analytical And Problem-Solving Skills, With The Ability To Identify And Resolve Quality Issues.
Excellent Communication And Interpersonal Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams And Communicate With Regulatory Agencies.
Quality Assurance
Project Management
Data Analysis
GMP Knowledge
Root Cause Analysis
Team Leadership
Risk assessment
Audit management
Regulatory compliance
Training and Development
SOP Development
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Sr Associate Plant QA in New Albany, OH, USA is $60,000 - $85,000 per year. This may vary depending on the specific company, experience level, and other factors such as benefits and bonuses.
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Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.
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