Sr Associate QA

Amgen • Thousand Oaks, CA

2d • $82,082 - $111,052

About The Position

Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Sr Associate Quality Assurance
What you will do
Let’s do this. Let’s change the world. In this vital role you will be responsible to ensure that operations products are manufactured, tested, stored and distributed according to Good Manufacturing Practices (cGMP).

Requirements

• High school/GED + 4 years of Quality Assurance work experience
• Associate’s + 2 years of Quality Assurance work experience
• Bachelor’s + 6 months of Quality Assurance work experience
• Master's

Nice To Haves

• Demonstrated knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations.
• Experience with Quality Management System (QMS) processes
• Knowledge of quality metrics, Management Review processes, and continuous improvement methodologies.
• Experience supporting regulatory inspections, partner audits, and internal quality audits.
• Experience serving as a Quality Assurance representative within a manufacturing or quality organization.
• Excellent written and verbal communication skills, including the ability to present information to leadership and regulatory inspectors.

Responsibilities

• Supports and audits and inspections preparation, planning, execution and response activities as well as facilitating completion of compliance and regulatory requests
• Provides QA oversight for IQA and ensures area readiness as the IQA compliance representative. Support IQA quality events, change controls and risk assessments.
• Supports ATO Management Review activities and metric control plan adherence
• May perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations. May also support execution of these tasks.
• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
• Supports that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
• Supports Continual Improvement initiatives, programs and projects
• Alerts management of quality, compliance, supply and safety risks
• Represents the Quality Assurance during audits and inspections
• Completes required assigned training to permit execution of required tasks
• Responsible for complying with Good Manufacturing Practices and Good Documentation Practices

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED