Drug Substance Quality Assurance Specialist

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity-related conditions. 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.

Drug Substance Quality Assurance Specialist

What you will do

Lets do this. Lets change the this vital role within the Plant Quality Assurance organization the Drug Substance QA Specialist provides quality oversight and compliance support for Drug Substance manufacturing operations at Amgen. Under minimal supervision this role ensures adherence to cGMP requirements quality systems and regulatory expectations while partnering closely with Manufacturing Facilities & Engineering and other cross-functional teams to support safe compliant and reliable operations.

The Drug Substance QA Specialist will be a member of the Drug Substance Plant QA team and provide Quality oversight for Drug Substance Manufacturing and supporting Facilities & Engineering operations. Examples of Drug Substance manufacturing operations include Cell Bank Cell Culture and Purification. The individual will contribute to fostering a culture of Safety and Quality at Amgen Thousand Oaks. The QA Specialist provides Quality and Compliance oversight of GMP processes procedures investigations and utilization of the Amgen Quality Management System.

A primary responsibility of this role is providing Quality oversight and support for deviation management processes including investigation review and approval root cause analysis corrective and preventive action (CAPA) development effectiveness verification and timely closure of quality records. The QA Specialist partners closely with Manufacturing Facilities & Engineering Quality Control and other cross-functional stakeholders to ensure events are thoroughly investigated appropriately documented and resolved in accordance with regulatory requirements and site procedures.

Responsibilities also include reviewing and approving GMP documentation observing manufacturing operations identifying and escalating quality risks and providing guidance to operational staff to ensure compliance with established requirements and procedures. The individual proactively identifies and communicates quality compliance supply and safety risks to management and works collaboratively with stakeholders to drive timely resolution.

Responsibilities include:

• Provides Quality oversight review and approval of major deviation investigations ensuring events are thoroughly investigated appropriately documented and resolved in accordance with regulatory requirements and site procedures.

• Partners with Manufacturing Facilities & Engineering Quality Control and other cross-functional stakeholders to facilitate root cause analyses risk assessments corrective and preventive actions (CAPAs) and effectiveness verification activities.

• Maintains the safety of self and others actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements

• Observes GMP operations within a clean room environment and providing constructive feedback to staff and managers

• Reviews and provides Quality approval for GMP documentation such as revisions to procedures and GMP documents investigation reports for major deviations change control records corrective action / preventive action records and other GMP records

• Identifies and escalates significant quality compliance supply and safety risks to management and supports risk-based decision making.

• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.

• Participates as a QA team member process during regulatory inspections third party audits and internal audits

• Makes certain the Quality Management System processes are executed in accordance with established procedures

• May author and own cGMP documents and reports

• May also perform other duties as assigned

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The quality professional we seek will possess 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:

• Excellent interpersonal skills

• Excellent written and verbal communication skills ability to work in a team matrix environment and build relationships with partners

• Strong experience supporting deviation investigations root cause analysis CAPA development and Quality Management System processes

• Knowledge of contamination control strategies environmental monitoring programs and utility monitoring systems within GMP manufacturing environments

• Experience supporting or partnering with microbiology laboratories environmental monitoring programs aseptic operations or contamination investigations

• Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus

• Experience participating in managing and responding to corporate audits/regulatory inspections

• Experience with Quality Management Systems including Change Control and Risk Management

• Demonstrated ability with project management initiating and leading cross-functional teams leading and managing change

• Biology Chemistry or Engineering degree is desirable

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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