Sr. Associate QC Systems

Biopharma Careers; Dublin; On-site; EUR 53,000 - 71,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Associate, Quality Control, Investigations to lead and manage QC investigations within the Quality System, support CAPA, deviations, and change controls.

You will author investigation documents, participate in triage, ensure timely closure, focus on RFT and Lean, and collaborate with ADL network; requires 4+ years in biotech/pharma and strong communication.

Qualifications

• 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.

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 elevate or look for support

Skills

GMP investigations

QC knowledge

Communication skills

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.

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 elevate 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