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Sr Associate Quality Control

1 month ago

Thousand Oaks, United States Amgen Full time

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. 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.

Sr Associate Quality Control

What you will do

Let’s do this. Let’s change the world. In this vital role you will support the QC Immunoassay and General Testing team by performing testing and data review/approval for ELISA methodology assays, qPCR, Karl Fisher Moisture, BLE (Break loose and Extrusion) and UV Spectroscopy. Staff member may also perform additional testing such as Viscosity, Osmolality and Reconstitution Time.

Responsibilities:

  • Report, evaluate, trend and approve analytical data.

  • Troubleshoot, solve problems and communicate with partners.

  • Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.

  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

  • Implement protocols and perform assay transfer/validation and equipment qualification/verification.

  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

  • Participate in lab investigations.

  • Provide technical guidance.

  • Provide training to others.

  • May represent the department/organization on various teams

  • May interact with outside resources

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:

  • High school/GED + 4 years of Quality Control experience OR

  • Associate’s + 2 years of Quality Control experience OR

  • Bachelor’s + 6 months of Quality Control experience

  • Master's

Preferred Qualifications:

  • cGMP Experience

  • Experience in Immunoassay (ELISA methodology)

  • Experience using LIMS and/or SmartLab

  • Experience and knowledge of Method Transfer and Validation Process

  • Experience and knowledge of Data Integrity Requirements of QC Systems

  • Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)

  • Excellent problem-solving capabilities and attention to detail

  • Experience of collaboration within and across functional areas and outstanding customer service focus

  • Excellent written and verbal communication skills

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, we’ll 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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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Application deadline

External/Internal postings:

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.