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

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. 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, 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.

About the 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 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.

Responsibilities

• 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, including 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.
• Adhere to safety rules and maintain a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Requirements

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

• High school/GED + 4 years of Quality and/or GMP Manufacturing experience
• Associate’s degree + 2 years of Quality and/or GMP Manufacturing experience
• Bachelor’s degree + 6 months of Quality and/or GMP Manufacturing experience
• Master’s degree

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, and 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), TrackWise, CDOCS, etc.

Benefits

From our competitive benefits to our collaborative culture, we support your journey every step of the way.

• 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
  • 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, including remote and hybrid work arrangements, where possible

Pay

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.

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.