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

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens 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 Amgens plan to be a carbon-neutral company by 2027.

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

What you will do

Lets do this. Lets 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 sites 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
• Bachelors degree and 6 years of Quality and/or F&E and/or Manufacturing experience OR
• Masters 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 well 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!

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.

Salary Range