Are you a QC Analyst with LIMS system implementation experience in a Biotechnology/ Pharmaceutical/ GMP Environment?

This is a contract role based in Dublin.

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.

Senior Associate QC - LIMS/ LMES/ CIMS/ Empower Systems Implementation

Onsite Expectations: Hybrid (2-3 days onsite)

Overview:

This job specification outlines the general responsibilities associated with the role of Senior Associate responsible for LIMS/ LMES/ CIMS/ Empower support at Amgen Dun Laoghaire.

This role will be responsible for administration and technical support in conjunction with the BPO for the QC Enterprise systems LIMS/ LMES/ CIMS/ Empower.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities

Work with site business process owners to provide laboratory business administration, implementation and technical support services for LIMS (Thermo Sample Manager), Biovia Smartlab (LMES) and Biovia CIMS (Inventory Management), Empower (Chromatography Data system).

Build, develop and maintain LIMS templates.

Evaluate new or revised eProcedures in conjunction with lab SMEs.

Provide support for LMES eProcedure implementation e.g. CIMS updates and SOP updates.

Provide end user support for LIMS.

Review and Approval of Quality Documentation e.g. Sample Plans FORMs and Environmental Monitoring sample plans.

Contribute to Computer System Validation activities within the QC laboratory.

Develop and deliver training for laboratory LIMS/ LMES/ CIMS/Empower requirements in adherence to Amgen requirements, SOPs, Standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems.

Identify, manage and implement continuous improvement projects related to laboratory applications and improving user experience.

Work with site business process owners to evaluate system practices for compliance and ensure the system’s application user operations procedures are accurate and effective for the application.

Partner with the global Master Data Group as needed.

Provide input on global level topics related to LIMS/ LMES/CIMS/ Empower.

Provide Instructor led training for QC laboratory applications as required.

Audit and Inspection preparation and participation as required.

Knowledge and Experience:

Hold a third level qualification in a Science related discipline

3 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment with previous experience as a user (at a minimum) for LIMS/LMES/CIMS/ Empower.

Familiar with laboratory information systems and can self-teach technical topics.

Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.

Knowledge on Data Integrity Assessments (DIA) for computerised systems and execution of CFR 21 Part 11 for computerised systems.

Excellent Organisational Skills and Time Management.

Strong Communication Skills.

Ability to work under minimal supervision.

Ability to identify and manage competing priorities.

Package

Contract role

Hybrid working available

Hourly Rate €35 - €40 per hour

Minimum 12 month contract

Contact

Karen McHugh is the consultant managing this position.

If you are a LIMS Templator interested in roles based in Dublin, you can contact Karen by e-mail 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 LIMS Templators in Dublin and Ireland.

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

taglife