QC Associate I

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. 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.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the AmgenFleXbatch facility will combine the latest insingle usetechnologies with traditionalstainless-steelequipment to allow for maximum flexibility in facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Associate Quality Control

What you will do

Lets do this. Lets change the this vital role you will be performing testing within the Quality Control Microbiology laboratory. Responsibilities will include sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program to deliver site start up and then transition to testing in support of Amgen North Carolina commercial product release. Scope includes in-process release stability and routine monitoring testing. The Associate Quality Control Environmental and Utilities Monitoring will report directly to the Manager of Microbiology.

• Support document review and authoring including but not limited to: SOPs safety assessments methods trend reports microorganism assessments and technical reports.

• Assist with execution of EMPQ activities to support establishment of environmental monitoring program.

• Perform routine environmental monitoring and utilities sampling.

• Perform routine quality control testing including Bioburden Endotoxin conductivity and TOC.

• Participate in audits initiatives and projects that may be interdepartmental or global in scope.

• Participate in deviations CAPAs and cross functional investigations.

• Assist with general lab setup and 5S.

• Support routine activities over the weekends and public holidays as required.

• Assist with clean utilities performance qualifications including water for injection clean steam clean compressed air oxygen and carbon dioxide distribution systems.
• Support routine activities over the weekends and public holidays as required.
• Perform routine tasks such as cleaning and inventory management.

What we expect of you

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

Basic Qualifications:

• High school/GED 2 years of related GxP laboratory experience OR
• Associates 6 months of related GxP laboratory experience OR
• Bachelors

Preferred Qualifications:

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in Microbiology Biology Biochemistry or related scientific field.
• Experience with microbiological quality control testing including but not limited to: Endotoxin Bioburden Microbial Identification TOC PCR.
• Strong knowledge of aseptic technique.
• Experience with environmental monitoring and clean utilities monitoring.
• Proficient in Good Documentation Practices.
• Strong written and verbal communication skills including technical writing and technical presentations.
• Able to flexibly work independently with minimal supervision and collaboratively on group tasks.

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.

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