Associate Quality Control - TIM Lab Analyst

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.

Associate Quality Control - TIM Lab Analyst

What you will do

Let’s do this. Let’s change the world. In this vital role you will be expected to primarily provide testing of HPLC and CE assays and to ensure quality and operational excellence within the HPLC/CE team at the Amgen Thousand Oaks Site. Responsibilities include performing sample testing and approval, performing supporting activities such as SOP/method revision, equipment validation, method transfers, and general troubleshooting. This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make relevant improvements in the QC space.

Responsibilities:

• Report, evaluate, trend and approve analytical data.

• Troubleshoot, solve problems and communicate with team members.

• 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.

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

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

• Responsible for CEMS on call pager.

• May participate in lab investigations.

• May provide technical guidance.

• May train others.

• May represent the department/organization on various teams

• May interact with outside resources

• cGMP Experience

• Experience in Capillary electrophoresis

• Experience using Empower CDS, LIMS and/or SmartLab

• Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation

• 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

Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more of the following activities:

• Performing routine laboratory procedures

• Routine analytical testing

• Documenting, computing, compiling, interpreting, and entering data

• Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents.

• Must learn and follow safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

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 + 2 years quality control work experience OR

• Associate’s + 6 months quality control work experience OR

• Bachelor’s

Preferred Qualifications:

• Ability to adhere to regulatory requirements, written procedures and safety guidelines

• Ability to evaluate documentation/data according to company and regulatory guidelines

• Ability to organize work, handle multiple priorities and meet deadlines

• Strong written and oral communication skills

• Must be detail orientated

• Must be flexible and adaptable to changing priorities and requirements

• Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance

• Demonstrates understanding of when and how to appropriately escalate.

• May identify, recommend and implement improvements related to routine job functions.

• Must learn and align with safety guideline and cGMPs.

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 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.

careers.amgen.com

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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.