Career CategoryQuality
Job DescriptionSpecialist Quality Assurance - Environmental Control ProgramMultiple positions availableWhat you will doLet's do this. Let's change the world! In this vital role, you will provide expert technical support, quality leadership, and compliance guidance for the timely resolution and effective management of routine and non-routine Environmental Monitoring (EM) and Contamination Control matters across AML. This includes continuous oversight of EM programs for manufacturing classified areas, critical utility systems, and site GMP and non-GMP operational areas.
As a Subject Matter Expert (SME) within the site Quality Operations team, this role provides technical advice and direction for complex operational deviations with potential impact to product quality. As Specialist QA within the Environmental Control Team (ECP), you will serve as the site's primary contact and liaison to the Amgen Contamination Control network and will represent the site before regulatory agencies on related matters.
Specific responsibilities include but are not limited to: - Ownership and leadership for the sustainability of the AML Environmental Monitoring program for classified areas and critical utility systems.
- Deliver expert quality and technical support for the resolution of complex contamination control investigations.
- Review environmental monitoring data and trend reports, including expert interpretation of raw data from primary sources.
- Apply the EM subject matter expertise during troubleshooting events and present EM program performance during audits and inspections.
- Advise on the acceptability of gowning outfits and consumable manufacturing materials, including requirements for implementation within site GMP operational areas.
- Contribute to the specification and design of garments used in aseptic and cleanroom environments.
- Drive the design and implementation of procedural controls and sampling strategies to monitor the performance of critical classified manufacturing processing areas.
- Develop justifications and scientific rationales for the selection of sampling locations within production and engineering systems intended for contamination control.
- Execute risk assessments to support the sustainability of the site Environmental Monitoring programs.
- Ensure site alignment with Amgen Contamination Control network multisite procedures, standard practices, and applicable regulations to maintain compliance.
- Apply statistical tools and methodologies to environmental control trending and monitoring analysis.
- Develop protocols to mitigate quality and operational contamination events across AML, including cleaning and sanitation procedures, disinfectant implementation and qualification, and microbiological sampling techniques for contamination control prevention.
What we expect of you We are all different! Yet, we all use our unique contributions to serve patients. The Specialist QA professional we seek is a Quality-driven professional with these qualifications.
Basic Qualifications: Doctorate degree
OR
Master's degree and 2 years of Quality Assurance GMP regulated industry experience
OR
Bachelor's degree and 4 years of Quality Assurance GMP regulated industry experience
OR
Associate's degree and 8 years of Quality Assurance GMP regulated industry experience
OR
High school diploma / GED and 10 years of Quality Assurance GMP regulated industry experience
Preferred Qualifications: - Educational background in Microbiology, Industrial Microbiology, and/or Life Sciences.
- Experience working in GMP-regulated manufacturing environments with a strong quality mindset in the production of sterile biological products.
- Experience in drug product and parenteral manufacturing operations.
- Experience conducting trending, monitoring, and oversight of cleaned, controlled, and classified environments for sterile and non-sterile manufacturing areas.
- Proficient in establishing environmental control procedures and assessing gowning systems for personnel working within controlled environments.
- Experitse in troubleshooting contamination events, determining action plans, and proposing compliant solutions to address complex contamination control problems.
- Proficient in developing expert protocols to mitigate quality and operational contamination events.
- Strong experience conducting scientific data gathering, analysis, interpretation, and reporting of expert technical documents to diagnose the state of microbiological control of facilities and critical utilities, including water for injection.
- Experience with aseptic process validation and/or airflow visualization is a plus.
- Effective English written and verbal communication skills, with strong project management, presentation, information systems, and interpersonal skills to support performance within complex matrix organizations.
What you can expect of usAs 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.
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 & vision coverage, and life & disability insurance
- 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.comIn 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.
SponsorshipSponsorship 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.
