Senior Associate Quality Assurance

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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

Let’s do this! Let’s 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:

• Master's Degree OR

• Bachelor's Degree & 6 months of cGMP experience OR

• Associate's 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

• Bachelor’s 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 r