Quality Assurance Senior Associate, Drug Substance Plant

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.

Quality Assurance Senior Associate Drug Substance Plant

What you will do

Lets do this! Lets change the world!

In this role as Senior Associate QA you will be responsible for providing quality oversight to Drug Substance manufacturing facilities at Amgen Thousand Oaks working within a shift system. Under general supervision you will support and ensure compliance for Manufacturing Facilities and Engineering staff in their processes procedures and use of quality systems. You will engage directly with a diverse range of partners establishing effective working relationships with production operators line leads shift supervisors warehouse staff facilities maintenance and engineering teams. This role requires your local presence at the Amgen Thousand Oaks (ATO) site.

Responsibilities:

• Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions.

• Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems.

• Serve as the first point of contact for quality-related production queries during DS operations.

• Lead mentor and coach Operations and support personnel on quality matters fostering a strong Quality culture at the site.

• Review and approve batch production records and other GMP documentation to support daily operations.

• Compile and review batch records for manufactured lots in preparation for batch disposition.

• Own review and approve controlled documents including SOPs Work Instructions and Forms.

• Collaborate effectively within a team matrix environment.

• Work across a three shift rotation including night shift.

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 an individual with these qualifications.

Basic Qualifications:

• High school/GED 4 years quality assurance work experience OR

• Associates 2 years quality assurance work experience OR

• Bachelors 6 months quality assurance work experience

• Masters

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelors Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time and high-quality results

• Ability to operate in a matrixed or team environment

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.

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.

Salary Range