Senior Associate- Quality Assurance Validation (QAV)

Career Category

Job Description

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. 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.

Senior Associate- Quality Assurance Validation (QAV)

What you will do

Let’s do this! Let’s change the world!

The Quality Assurance Senior Associate is a vital role for ensuring quality and compliance are built into the new Amgen North Carolina (ANC) facility from the start. The initial focus of the role will be to provide quality support of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. You will collaborate cross-functionally to ensure project timelines and milestones are met. Once the site is operational, this role will continue to provide validation support, as well as quality support for all non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects.

• Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site, as well as periodic reviews and other core day-to-day- tasks. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.

• Perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.

• Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.

• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Work Instructions, Forms, etc.

• Provide quality assistance on quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate.

• Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

• Support on-site audits and inspections.

• Support continuous improvement initiatives.

• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school/GED + 4 years Quality and/or Operations experience OR

• Associate’s + 2 years Quality and/or Operations experience OR

• Bachelor’s + 6 months Quality and/or Operations experience OR

• Master’s degree

Preferred Qualifications:

• Understanding of regulatory requirements, trends, and industry standards.

• Experience/knowledge in commissioning/qualification/validation, including computer-systems validation.

• Excellent written and verbal communication skills.

• Ability to work in a team matrix environment and build relationships with partners.

• Great attention to detail and high degree of accuracy in task execution and GMP documentation.

• Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion.

• Proven c