Specialist QC

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.

Specialist Quality Control Microbiology

What you will do

Lets do this. Lets change the this vital role you will lead the Environmental Monitoring and Utilities Monitoring programs to support the drug substance manufacturing facilities. The Specialist Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. This role may have a limited number of direct reports.

Responsibilities:

• Provide site-level leadership and strategic ownership of the Environmental Monitoring (EM) and Utilities Monitoring programs ensuring sustained compliance data integrity and a proactive state of control across manufacturing operations.
• Serve as the primary subject matter expert (SME) for environmental monitoring utilities monitoring and contamination control providing expert guidance to site leadership cross-functional partners and global stakeholders.
• Establish oversee and continuously improve monitoring strategies including data review trend analysis interpretation and presentation to support risk-based decision making.
• Author review and approve GMP documentation and technical deliverables including SOPs safety assessments trend reports qualification and validation summary reports microorganism assessments and other technical reports.
• Lead the planning and execution of Environmental Monitoring Performance Qualification (EMPQ) activities in support of facility changes expansions and new initiatives partnering closely with QC Micro Sampling and Testing teams.
• Provide technical oversight and governance for Clean Utilities qualification activities ensuring alignment with regulatory expectations and internal quality standards.
• Drive cross-functional alignment with Manufacturing Facilities & Engineering Quality and other stakeholders to ensure monitoring programs support both compliance and business objectives.
• Drive the site Contamination Control Strategy participating in contamination risk assessments and ensuring effective implementation monitoring and continuous improvement in alignment with global standards.
• Represent the site in global environmental monitoring and contamination control forums influencing best practices sharing expertise and driving harmonization across the network.
• Deliver clear data-driven communication to site leadership including routine presentations on environmental and utilities monitoring performance risks trends and mitigation strategies.
• Lead and support regulatory inspections internal audits and cross-functional initiatives of site or global scope serving as a technical authority during audits and inspections.
• Support QC Microbiology laboratory investigations and deviation investigations ensuring timely resolution robust root cause analysis and sustainable corrective and preventive actions.
• Provide operational leadership and escalation support for routine monitoring activities including coverage during weekends and public holidays as required to maintain compliance and operational readiness.
• This may include scheduling and coordinating routine or qualification activities with manufacturing operations

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The motivated is an experienced quality control analyst these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality or Aseptic Manufacturing experience OR
• Associates degree and 8 years of Quality or Aseptic Manufacturing experience OR
• Bachelors degree and 4 years of Quality or Aseptic Manufacturing experience OR
• Masters degree and 2 years of Quality or Aseptic Manufacturing experience

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 environmental monitoring and clean utilities monitoring including execution of EMPQ and trending of EM/utilities data.
• Experience with microbiological quality control testing including but not limited to: Endotoxin Bioburden Microbial Identification TOC.
• Experience with regulatory inspections
• Strong knowledge of aseptic technique.
• Strong written and verbal communication skills including technical writing and technical presentations.
• Able to flexibly work independently as a project owner collaboratively on group tasks and as a trainer.

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.

Salary Range