Sr. Associate Quality Control, Microbiology

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 Control - Microbiology

What you will do

Lets do this. Lets change the world!

In this vital role you will support the QC Microbiology and Environmental Monitoring team by performing activities including microbial investigations/assessments microbiological and analytical testing sample and data management equipment and instrumentation operation and maintenance sample and equipment troubleshooting and the review and authorization of documents and samples while performing in a highly dynamic team-oriented environment.

Responsibilities include:

• Perform microbial assessments and other GMP documentation as required (reports assessments SOP revisions).

• Support microbial and other QC laboratory investigations.

• Perform Microbiological testing to support GMP operations across ATO

• Perform Microbiological sample and method qualifications including bioburden microbial identification sterility and other microbiological assays as assigned.

• Perform testing and data review for compendia non-compendia methods and routine laboratory procedures.

• Generate complete accurate and concise laboratory documentation using electronic systems such as LMES LIMS and laboratory notebooks.

• Operate and maintain specialized laboratory equipment and instrumentation.

• Perform general laboratory housekeeping activities and safety inspections.

• Maintain training compliance and proficiency.

• At all times comply with safety guidelines cGMPs and other applicable regulatory requirements.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek is an innovator with these qualifications

Basic Qualifications:

• High school/GED 4 years of Quality experience OR

• Associates 2 years of Quality experience OR

• Bachelors degree and 6 months of Quality Microbiology or Operations experience

• Masters degree

Preferred Qualifications:

• Professional work experience in a fast-paced flexible GMP laboratory.

• Leadership ability to assist with the daily/weekly schedule routine and non-routine testing and sample collection questions and issues and equipment troubleshooting.

• Experience executing microbial test methods (i.e. bioburden microbial identification growth promotion qPCR sterility etc.).

• Experience supporting Environmental and Clean Utility Monitoring programs.

• Operation maintenance experience with laboratory equipment.

• Ability to generate and revise methods reports and SOPs within CDOCs.

• Demonstrated proficiency with electronic systems (LIMS LMES CIMS CDOCS etc.).

• Ability to generate update triage and close deviations and analytical test result assessments.

• Demonstrated understanding and use of Maximo and the ability to update and complete work orders.

• Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs.

• Demonstrated written and oral communication skills project management and presentation skills and proven ability to manage priorities effectively.

• Demonstrated ability to be flexible and adaptable to support business needs.

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.

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