QC Microbiology Sr. Associate

Amgen Foundation, Inc.; Dún Laoghaire; À distance; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Amgen is seeking a Sr Associate Quality Control to support manufacturing operations on a 24/7 shift pattern, onsite in Ireland. The role focuses on environmental monitoring of cleanrooms, bioburden testing, water sampling, and generating EM trend reports.

Fluency in GMP regulatory standards and ability to work with cross-functional teams are essential. The position requires a bachelor's degree in a science discipline and prior Biopharmaceutical QC experience in a microbiology lab.

Qualifications

• Bachelors degree in a science discipline.
• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Responsabilités

• Environmental Monitoring of Grade 8/9 Cleanrooms.
• Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators.
• Reading of Environmental Monitoring Plates.
• Bioburden testing of water & disinfectants.
• Writing technical reports such as monthly and annual EM trend reports.
• Water sampling.
• Testing of In Process samples such as pH.
• Testing of Biological Indicators.

Connaissances

Biology & microbiology

Quality control

Leadership & communication

Problem solving

Regulatory interaction

Formation

Bachelor's degree in science

Outils

LIMS

Trackwise

SAP

CDOCS

LMES

Description du poste

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Sr Associate Quality Control

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

Shift 24/7

Onsite

Specific Job Duties

• Environmental Monitoring of Grade 8/9 Cleanrooms
• Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators
• Reading of Environmental Monitoring Plates
• Bioburden testing of water & disinfectants
• Writing technical reports such as monthly and annual EM trend reports
• Water sampling
• Testing of In Process samples such as pH
• Testing of Biological Indicators

Competencies

• Technically strong background in microbiology and aseptic manufacturing
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
• Flexibility – the EM role often encounters changing priorities on a daily basis
• Problem solving skills
• Experience with Regulatory inspectors and interacting with inspectors desirable
• Demonstrated ability to work independently and deliver right first time results
• Works under minimal direction
• Work is guided by objectives of the department or assignment
• Follows procedures, GxP and DI practices.
• Refers to technical standards, principles, theories and precedents as needed
• May set project timeframes and priorities based on project objectives and ongoing assignments.
• Recognizes and escalates problems
• Demonstrated leadership and communication skills
• Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies

Basic Qualifications

• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

Preferred Qualifications

• Experience working in an aseptic cleanroom performing Environmental Monitoring
• Proficient in the use of LIMS & LMES

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.