Sr Associate, Manufacturing; Technical Authoring​/Deviation Investigations

Overview

Join Amgen’s mission of serving patients. 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 a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. 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.

Support the manufacturing team and provide technical expertise by drafting and revising documents such as Standard Operating Procedures, protocols, technical reports, and training material in a GMP‑regulated environment that supports the manufacturing process.

• Develop, review, and update technical content including but not limited to SOPs, work instructions, risk assessments, protocols, and reports.
• Provide technical and clerical support in the preparation of documentation, collation of data, and tracking of technical documents.
• Liaise with manufacturing and cross‑functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new or revised training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and/or troubleshooting projects.
• Reduce document turnaround times for the manufacturing team.
• Ensure documentation‑related actions are completed on time and the schedule remains current and accurate.
• Develop protocols for Manufacturing to support change controls, deviations, and troubleshooting investigations with input from relevant SMEs.
• Own and provide subject‑matter expertise for Quality System records such as minor deviations, CAPA, complaints, and change control records.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to maintain GMP standards in line with current operating systems.
• Share knowledge with members of the manufacturing team.

The professional we seek will possess the following qualifications.

• High school/GED + 4 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• Associates + 2 years in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• Bachelors + 6 months in Manufacturing, Packaging, or Quality experience in pharmaceutical, medical device, or biotechnology companies.
• Master’s degree in a related field.

• Educational background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a GMP environment and demonstrated background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into understandable information for manufacturing operators.
• Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts to increase user understanding.
• Experience supporting deviations, investigations, CAPAs, and change controls.
• Fact‑based problem solver with strong troubleshooting and problem‑solving skills.
• Pro‑active with the ability to prioritize work to meet benchmarks.
• Strong documentation and communication skills.

In addition to the base salary, Amgen offers a Total Rewards Plan, which includes a comprehensive employee benefits package, discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible.

Sponsorship for this role is not guaranteed.

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.

Please contact us to request accommodation.