Senior QA Specialist- Quality Assurance Validation & Tech Support – Facilities & Utilities Focus

Career Category

Quality

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior QA Specialist- Quality Assurance Validation & Tech Support – Facilities & Utilities Focus

What you will do

Let’s do this. Let’s change the world. This vital role will provide quality assurance oversight to both the existing and new Amgen North Carolina (ANC) facilities, ensuring compliance is built into the design and maintained throughout the lifecycle. This role collaborates with the Global Capital Project, Site Facilities & Engineering (F&E), Process Development and Manufacturing teams to oversee QA for clean utility operations throughout their lifecycle at the Amgen North Carolina manufacturing site.

With site expansion, the QAV & TS team seeks a Sr. QA Specialist to establish strategy for the project as its scope increases. This role covers design, planning, construction oversight, and operational readiness. This role requires leadership attributes and expertise to ensure effective results and apply lessons from the current facility to the growing site.

The initial focus of the role will be to provide quality oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. You will work across teams to meet project deadlines and milestones. Once the site is operational, this role will continue to provide site wide validation oversight, as well as quality oversight for all non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects.

• Perform quality review and approval of documents to support facility commissioning and qualification, Validation Protocols, Validation Reports, according to project timelines.
• Give QA perspective on PPQ and cleaning validation for ANC site's facilities, utilities, and equipment.
• Provide QA oversight and partner to troubleshoot problems as they occur on ANC utility systems (i.e Water for Injection, Compressed Air, Clean Steam, CIP Skids, Water/Steam Sampling, Process Gases, and other equipment related to clean utilities)
• Provide quality guidance and support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
• Author and own, controlled documents, including Standard Operating Procedures, Work Instructions, Forms, etc.
• Provide quality oversight for 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 and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Engage with global networks to influence standard methodology and continuous improvements across Amgen sites.
• Lead and 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 Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality, and/or F&E, and/or Manufacturing experience OR
• Associate degree and 10 years of Quality, and/or F&E, and/or Manufacturing experience OR
• Bachelor’s degree and 6 years of Quality, and/or F&E, and/or Manufacturing experience OR
• Master’s degree and 4 years of Quality, and/or F&E, and/or Manufacturing experience OR
• Doctorate degree and 2 years of Quality, and/or F&E, and/or Manufacturing experience

Preferred Qualifications:

• Strong understanding of regulatory requirements and trends, and industry standards.
• Knowledge in the following:
• WFI Systems
• CIP & Chemical delivery systems
• Clean Steam Systems
• Clean Air Systems
• Pharmaceutical Grade Compressed Gasses
• Experience/knowledge in commissioning/qualification/validation, including utility systems and cleaning validation.
• Previous experience in validation or QA oversight of C&Q and validation activities in a multitude of facets (process, utilities, QC, or equipment) desired.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
• Provide QA oversite when leading through change by being able to adapt to an ever-changing environment
• Demonstrable understanding of GxP compliance, capability, and have experience applying GMP requirements in an operational setting.
• Must be highly organized and capable of working in a team environment with a positive attitude under minimal direction.
• Ability to define and implement a clear course of action to deliver results in a high pace environment.
• Ability to work in a team matrix environment and establish relationships with partners.
• Ability to provide sound quality guidance and make data-driven, risk-based, decisions.
• Excellent written and verbal communication skills.
• Phenomenal attention to detail and high degree of accuracy in task fulfillment and GMP documentation.
• Ability to provide updates to senior management, identifying potential issues, and following assignments through to completion.
• Ability in problem solving and driving improvement.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team!

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

141,158.00 USD - 164,599.00 USD