QC Specialist Separations

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Ringaskiddy, Cork, Ireland

Job Description:
We are searching for the best talent for a QC Specialist - Separations.

Purpose

We are looking for a QC Specialist - Separations to join our Quality Control team.

In this role, you will provide technical expertise and support for Quality Control laboratory activities within a regulated pharmaceutical manufacturing environment.

You will work closely with laboratory teams and cross-functional partners to support analytical testing, equipment qualification, method transfer activities, investigations, and continuous improvement initiatives.

The role requires sound technical knowledge of analytical techniques and laboratory equipment in one or more of the following areas: Chemistry, Biochemistry, or Microbiology.

Previous supervisory experience in an IMB/FDA-regulated environment is required.

You will be responsible for

Working closely with the QC Manager and laboratory teams, you will provide technical support for testing operations and contribute to the delivery of compliant and efficient Quality Control activities.

Key responsibilities include:



* Supporting day-to-day testing operations


* Coordinating qualification of analytical equipment and associated testing functions, including technologies such as HPLC, Spectrophotometry, Nephelometry, and Total Organic Carbon systems


* Coordinating sampling and testing activities during plant and laboratory utility qualification


* Planning and coordinating analytical method transfer activities for relevant New Molecular Entities (NMEs)


* Coordinating analytical testing and sampling activities for raw materials, utilities, in-process samples, final bulk, and finished products


* Supporting implementation of analyst training programs


* Reviewing and approving laboratory data and Quality Control investigations


* Reviewing specifications and supporting associated LIMS scheduling activities


* Reviewing and approving deviations, CAPAs, and Change Controls


* Planning and overseeing laboratory proje...