QC Senior Associate - (QC sample management)

Global Biotechnology company based in south Dublin, Ireland – looking for QC Senior Associate.

The successful candidate will be responsible for one or more of the following activities in QC including sample and data management and equipment maintenance. This role will support QC and manufacturing operations, as some extended hours and weekend work flexibility may be necessary as required.

The Job:

* Execute sample management activities across the site – sample distribution, LIMS logging, shipment receipt.
* Perform Stability Program related activities such as pulling stability samples and study initiations.
* Create/own and approve protocols, sample plans., SOPs, training manuals.
* Perform SAP, LIMS and CIMS functions/ transactions within the sample management remit
* Out-of-hour responder for sample management equipment (fridges /freezers / incubators)
* Responsible for their own training and safety compliance.
* Sample shipments and temperature monitoring activities.
* LIMS data coordination of commercial and import batches.
* Management and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples.
* QC Representative for NPI activities and routine Product meetings as required.

Have You:

* Bachelor’s degree in a Science related field is required.
* 4+ years of bio-pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability program experience is desirable.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
* Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.
* Auditing documentation and operation process.
* Demonstrated ability to interact with regulatory agencies.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com