Senior Associate Quality Assurance

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. 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.

Senior Associate Quality Assurance

What you will do

Lets do this! Lets change the world!

The Sr. Associate QA will be a member of the Amgen Thousand Oaks Clinical Final Drug Product QA team. Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks label approval and packaging inspection will have no foundation. The Sr. Associate QA must be able to methodically and meticulously inspect printed materials for print quality defects clinical product components (e.g. syringes and vials) for physical defects and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities such that the team members must be confident verbal communicators able to discuss responsibilities divide them reassess them and potentially reassign them throughout the day or week. The Sr. Associate QA may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

Responsibilities include:

• Internal Quality Assurance support for Final Drug Product Packaging

• Review and approval of printed clinical labels

• Finished clinical pack inspection

• Expiration date calculation

• Electronic batch record review

• GMP Document (SOPs/FORMs) revision review/approval

• Review and approval of electronic Maintenance documentation Work Order/Job Plans.

• Quality support and approval of minor deviations

• Electronic Batch Record (MES) documentation revisions and approval.

• Quality support and approval of minor deviations

• Internal Quality Assurance support for creation and revision of GMP procedures including document review approval and archival

• Generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports.

• Alerts management of significant quality compliance supply and safety risks

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

• The successful candidate will have experience working in multiple GMP databases

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 employee with these qualifications.

Basic Qualifications:

• Masters Degree OR

• Bachelors Degree & 6 months of cGMP experience OR

• Associates degree & 2 years of cGMP experience OR

• High school diploma/GED & 4 years of cGMP experience

Preferred Qualifications:

• Quality and Manufacturing experience in biotech or Pharmaceutical industry

• Bachelors Degree in Science field

• Familiarity with basic project management tools

• Ability to successfully manage workload to timelines

• Previous experience with quality system transactions (SAP SM-LIMS Trackwise VeevaVault)

• Demonstrated experience creating deviation technical assessments or equivalent

• Demonstrated ability to perform GMP operations including following detailed SOPs maintaining training and adhering to good documentation practices.

• Proficient with database use including data input archival and query retrieval

• Strong attention to detail and high degree of accuracy in task execution and GMP documentation

• Highly effective verbal and written communication skills strong interpersonal skills

• Ability to complete tasks autonomously provide updates to area manager and identify potential issues

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