Job Description

Career Category

Operations

Senior Document Control Associate (Technical Writer) Job Description

An exciting opportunity has opened in the ADL Manufacturing Support team for a Technical Writer. In this role, you will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.

This role is primarily based on site at Amgen Dun Laoghaire.

Primary Responsibilities:

• Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner
• Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
• Involvement in projects as part of continuous process improvement and / or troubleshooting
• Ownership and management of change controls as required
• Issuance and updates of paper batch records in line with production schedule
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current Operating Standard
• Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
• Perform document trending upon project completion to identify keys issues/mistakes in document processing.
• Support data verification of Operations owned protocols reports and risk assessments.
• Support the production support team in reducing document turnaround times
• Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs
• Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs
• Ensure deviations are triaged within the established timeframe and serve as a deviation owner for minor deviations.
• Own corrective /preventative actions and effectiveness verification.
• Support execution of C&Q, characterisation, functional testing protocols as required by project.
• NOTE: This role may require flexible working hours.

Knowledge/Skills:

• Strong Project Management and organizational skills, including ability to follow assignments through to completion
• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
• Escalate issues professionally and in a timely manner
• Ensures compliance within regulatory environment
• Demonstrated ability to work independently and deliver right first-time results under minimal direction
• Experience participating in and leading cross-functional teams
• Experience in managing multiple, competing priorities in a fast-paced environment

Relevant Experience:

• Bachelor’s degree in a Science or Engineering discipline.
• 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage