Sr. Associate Plant QA Night Shift

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 illnesses drives 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 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.

Lets do this. Lets change the world. In this role As Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed t to that, you will provide support in different QA related projects/systems.

In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.

Lets do this. Lets change the world. In this vital role you will:

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.

• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.

• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.

• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.

• Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place

• Perform finished product checks during (commercial) production runs

• Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.

• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.

• Review and approve Deviation, CAPA, and Change Control records.

• Participate in self-led inspections and provide support during internal / external regulatory inspections.

• Support Lean Transformation and Operational Excellence initiatives

• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with any of these qualifications.

Basic Qualifications:

High school/GED + 4 years of Quality and/or GMP Manufacturing experience

OR

Associates + 2 years of Quality and/or GMP Manufacturing experience

OR

Bachelors + 6 months of Quality and/or GMP Manufacturing experience

OR

Master's

Preferred Qualifications:

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies

• Experience in and knowledge of GMP/GCP operations or similarly regulated industry

• Affinity with digital innovation, data sciences and Quality engineering

• Experience with raw material receipt, inspection & sampling

• Highly effective verbal and written communication skills, strong interpersonal skills

• Great attention to detail and high degree of accuracy in task execution and GMP documentation

• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

• Strong organizational skills, including ability to follow assignments through to completion

• Direct experience with Enterprise Resource Management software (SAP), Track Wise, CDOCS etc.

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…