Sr. Associate QC Systems
About this opportunity
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 escalate 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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 185 comparable Senior Quality roles across 58 biopharma companies.
Salary context
57 of 185 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 185 comparable roles
+ 23 more countries
Seniority mix
185 of 185 peers have a known seniority level
Therapeutic area mix
0 of 185 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.