Sr Associate, Manufacturing (Technical Authoring/Deviation Investigations)

Responsibilities

• Develop, review, and update technical content including SOPs, work instructions, risk assessments, protocols, and reports for the manufacturing team.
• Provide technical and clerical support in documentation preparation, data collation, and tracking of technical documents.
• Liaise with manufacturing and cross-functional departments regarding documentation changes and training material updates.
• Support process owners in continuous process improvement and troubleshooting projects.
• Develop protocols to support change controls, deviations, and troubleshooting investigations.
• Generate and provide subject matter expertise for Quality System records, including minor deviations, CAPA, complaints, and change control records.
• Ensure all documentation related actions are completed on time and maintain accurate, up-to-date schedules.
• Collaborate with Quality Assurance to ensure GMP standards are maintained.

Requirements

• High school/GED + 4 years of experience in Manufacturing, Packaging, or Quality within pharma, medical device, or biotech.
• OR Associate’s degree + 2 years of relevant experience.
• OR Bachelor’s degree + 6 months of relevant experience.
• OR a Master's degree.
• Experience working in a GMP regulated environment.
• Strong technical writing and documentation skills.
• Proven problem-solving and troubleshooting abilities.

Preferred Qualifications

• Educational background in Science and/or Engineering.
• Experience with device assembly and packaging of final products.
• Ability to translate highly technical information into easily understandable instructions for operators.
• Proficiency in using visual aids such as photographs, drawings, diagrams, and charts to enhance understanding.
• Experience supporting deviations, investigations, CAPAs, and change controls.

Benefits

• Comprehensive health, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, leveraging biology to deliver innovative human therapeutics worldwide.