Aseptic Officer Specialist QA

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.

Specialist QA

What you will do

Lets do this. Lets change the this vital role within the Plant Quality Assurance organization the QA Specialist - Aseptic Officer provides aseptic subject matter expertise and oversight to operational activities associated with the aseptic Drug Product manufacturing areas at Amgen Thousand Oaks.

Under minimal supervision the role provides compliance and aseptic oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes procedures and use of quality systems. Duties include ensuring timely delivery and completion of records within our QMS focused on aseptic operations i.e. Deviations CAPAs Change Controls etc. document revision review and approval work order approval. The Aseptic Officer will also evaluate compliance and operational issues provide recommendations and assure progress of quality records to completion. The individual will also represent the B20 Quality function in projects as necessary to achieve departmental and plant goals and will work in a dynamic cross functional environment.

Responsibilities:

• Acts as the Quality organizations main point of contact and subject matter expert for all topics related to aseptic processing such as during processing issues or support for projects the environmental monitoring program deviation investigations and validation.
• Partners with our colleagues in Manufacturing Supply Chain Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
• Provide Quality Oversight of the manufacturing facility including manufacturing operations testing inspection and utilities.
• Participates in and provides quality oversight for quality records including Deviations Change Controls and CAPAs assuring adherence to procedural requirements and regulatory expectations.
• Perform impact assessments as part of change controls impacting production or QA processes.
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams. Reviews and approves controlled documents including but not limited to Standard Operating Procedures Protocols and Reports.
• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices Good Documentation Practices Safety and Controls.
• Participates in Amgen internal/external audits and inspections. Directly interacts with regulatory agencies during on-site inspections.
• Contribute to and drive continuous improvement projects in cross-functional collaboration. Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek is a dynamic employee with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years of quality experience

Or

Bachelors degree and 4 years of quality experience

Or

Associates degree and 8 years of quality experience

Or

High school diploma / GED and 10 years of quality experience

Preferred Qualifications:

• Bachelors Degree in Science
• 5 plus years of aseptic processing experience in QA or Manufacturing
• Experience with leading or supporting an aseptic program for Drug Product operations
• Excellent interpersonal verbal and written communication skills with all levels within the Organization
• Experience leading and directly coaching staff to drive improved performance and focus on operational excellence
• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions
• Experience applying problem solving tools for root cause analysis.
• Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
• Ability to independently interact with various levels drives tasks to completion and is a self-starter
• Applies project management principles and techniques

What you can expect from 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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 including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

Salary Range