Amgen Inc

Sr. Associate Plant QA 12 Hour Day Shift (6am - 6:30pm)

US - Ohio - New Albany · Senior

Sponsorship not specifiedDetected 1 day ago

GCPSAPGMPResearchCommunicationOrganizational Skills

About the role

Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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.

Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
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
Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Support Lean Transformation and Operational Excellence initiatives
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 at AOH.
Next 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.

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

The Quality professional we seek is a dynamic, flexible and driven individual with any of these qualifications.

We are all different, yet we all use our unique contributions to serve patients.

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.
Please contact us to request accommodation.
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.

This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.