Senior Quality Control Associate - Microbiology - Dublin

Office/Project Location: Dún Laoghaire, Dublin

Employment Type: 12-Month Contract (possibility of extension)

Pay: Hourly Rate €30 - €35

Experience:  3-5+ years' QC Microbiology laboratory experience within a cGMP 

Visa: EU passport or Stamp 4 visa required

Our client is a global biopharmaceutical leader specializing in the development, manufacturing, and commercialization of innovative human therapeutics.

A Senior QC Associate is required on a 12-month contract to join the Quality Control team at their state-of-the-art biomanufacturing facility in Dún Laoghaire, South Dublin.

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. 

This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. 

The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. 

This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.

Endotoxin testing of water, in-process and drug product release samples

Bioburden testing of water & in-process drug product samples

Sterility testing

Water sampling

Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.

Writing technical reports

Perform analytical testing as a main priority with efficiency and accuracy

With a high degree of technical flexibility, work across diverse areas within the lab

Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.

Report, evaluate, archive, trend and approve analytical data.

Troubleshoot, solve problems and communicate with stakeholders.

Initiate and/or implement changes in controlled documents.

Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

Write protocols and perform assay validation.

Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

Review and Approve lab results

May participate in lab investigations.

May provide technical guidance.

May train others.

May contribute to regulatory filings.

May represent the department/organization on various teamsMay interact with outside resources

Requirements

BSc (Level 8) in Microbiology, Biological Sciences, Biotechnology, or a related scientific discipline.

3-5+ years' post-graduate Quality Control laboratory experience within a licensed cGMP pharmaceutical or biopharmaceutical environment.

Hands-on proficiency in core microbiological methods: Endotoxin (LAL), Bioburden, Sterility testing (isolators), and Water sampling.

Strong working knowledge of GMP electronic systems (LabWare LIMS, TrackWise, SAP, LMES)

Solid understanding of regulatory pharmacopeial standards (Ph. Eur., USP, JP) and ALCOA+ data integrity principles.

Excellent technical writing, root cause problem-solving, and communication skills.

Flexibility to support manufacturing operational schedules, including participation in weekend on-call / rota coverage as required.

Package

Hourly rate €30-€35

12-month contract

Onsite day role

Contact

Karen McHugh is the consultant managing this position.

If you are a QC Associate interested in roles based in Dublin, you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of QC Associates in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

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