Sr. Associate QC Systems

Amgen Inc. (IR); Dublin; Hybrid; EUR 53,000 - 71,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Associate, Quality Control - Investigations to own the end-to-end lifecycle of Quality records within QC. The role emphasizes strong technical writing, root cause analysis, and problem-solving while ensuring investigations lead to robust CAPA and compliant processes.

You will collaborate across the QC function, participate in audits, and support change controls as needed, with minimal supervision and broad network engagement.

Qualifications

• Hold a third level qualification in a science related discipline.
• Minimum of 4 years’ experience in Biotechnology/ Pharmaceutical setting.
• Experience handling GMP investigations within a Quality System is advantageous.
• Detailed knowledge of the QC function and operational savvy.
• Excellent verbal and written communication including technical writing.

Responsibilities

• Owns and Manages Investigations for QC through DQMS.
• Author and review investigation documents.
• Participates in the investigation triage process.
• Ensures investigations are up to date and compliant with procedures.
• Ensures investigations result in robust CAPA to prevent recurrence.
• Seek opportunities to improve process and management of Investigations.
• Support Change Controls linked to investigations and CAPAs.
• Assist audits and inspections and represent QC at site and network level.

Skills

Root Cause Analysis

5 Whys

Technical writing

Problem solving

GMP Investigations

Education

Science degree

Job description

Career Category Quality Job Description Overview: This job specification outlines the general responsibilities associated with the role of Senior Associate, Quality Control, Investigations at Amgen Dun Laoghaire. The QC Systems team provide support to the QC function for all activities within Amgen’s Quality System associated with QC Deviation Investigations, CAPA records, Testing Results Assessments (TRA) and Change Controls. The successful candidate will own and manage the end-to-end life cycle of Quality records on behalf of Quality Control. The role has a strong focus on technical writing and problem-solving including Root Cause Analysis and 5 Why methodologies. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the QC support function.

Key Responsibilities

• Owns and Manages Investigations for QC through DQMS.
• Author and review investigation documents.
• Participates routinely in the investigation triage process.
• Ensures investigations are kept up to date and compliant with procedures.
• Ensure investigations result in robust CAPA to prevent recurrence.
• Seeking out opportunity to improve the process and management of Investigations.
• Strong focus on RFT and Lean.
• Build relationships and partners at ADL and in the network.
• May own Change Controls linked to investigations and CAPAs.
• Supports Audits and Inspections regarding preparation and participation.
• Represents QC at site and network level regarding Investigations.
• Works with minimal supervision but knows when to escape or look for support.

Knowledge and Experience

• Hold a third level qualification in a science related discipline
• Have a minimum of 4 years’ experience in Biotechnology/ Pharmaceutical setting.
• Proven Experience of handling GMP investigations within a Quality System an advantage.
• Detailed knowledge of the QC function and is operationally savvy.
• Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.

Salary Range 52,756.95 EUR - 71,377.05 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen