LIMS Analyst

Wallace Myers International; Munster; On-site; EUR 60,000 - 75,000; Full time

Job summary

Wallace Myers International is recruiting a LIMS Analyst to work in the Data Integrity stream at a Global Biopharma client site in Waterford. The role focuses on retrospective updates to LIMS analyses for micro and chemistry labs and automating interfaces between QC equipment and LIMS.

You will work with Thermo Sample Manager LIMS and engage with LIMS suppliers and stakeholders to ensure data integrity and regulatory compliance, including CAPA and inspection readiness.

Qualifications

• Experience with Sample Manager LIMS and LIMS interfaces is required.
• Strong data integrity understanding and hands-on configuring LIMS analyses.
• Experience in QC equipment integration with LIMS is essential.
• Familiarity with regulatory requirements and CAPA processes is preferred.

Responsibilities

• Ensure compliance with data integrity regulatory requirements and company policies.
• Perform regular data quality checks and validations to identify issues.
• Develop and deliver training on data integrity principles and practices.
• Identify and mitigate data integrity risks and implement CAPA actions.
• Ensure proper documentation practices for data recording, storage and retrieval.
• Lead continuous improvement initiatives to enhance data integrity.

Skills

LIMS

Data integrity

Regulatory compliance

Stakeholder management

Tools

Thermo Sample Manager LIMS

Job description

LIMS Analyst

Jenn Dinan at Wallace Myers is recruiting a LIMS Analyst to work in the Data Integrity Stream on contract at our Global Biopharma client's site in Waterford.

The focus of this role is to retrospectively update existing LIMS analyses (for Micro and chemistry labs) to optimize LIMS automation features like automated calculations and report/dashboard development. A key element of the role is to automate interfaces between QC equipment and LIMS. Experience with Sample Manager LIMS, and experience of working with LIMS suppliers and stakeholders is critical.

An experienced LIMS professional with strong DI understanding and hands on experience of configuring LIMS analyses and QC equipment integration (Thermo Sample Manager LIMS).

Job Purpose

The aim of the role is to ensure that Data Integrity is embedded in all aspects of work performed in Waterford and ensure that Regulatory and Global Quality requirements are cascaded to site functions to ensure that all Data Integrity requirements are met

Main Accountabilities

• Ensuring compliance with regulatory requirements and company policies related to data integrity
• Conducting regular routine data quality checks and validations to identify and address any data integrity issue
• Developing and delivering training programs on data integrity principles and practices
• Identifying and assessing risks related to data integrity and implementing mitigation strategies
• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval
• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA)
• Leading continuous improvement initiatives to enhance data integrity practices
• Overseeing the validation of computerized systems to ensure they meet data integrity requirements
• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity
• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity Model)
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
• Establish and prioritize data integrity objectives for the site
• Proactively identify remediation actions from findings from internal and external audits
• Identify training needs and content for data integrity
• Decide on corrective and preventive actions for data integrity issues
• Is informed of any breach in data integrity
• Advise on cross-departmental data integrity strategies
• Is informed of inspections and audits outcome

All applications will be treated with the strictest of confidence

Privacy Policy

By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see wallacemyers.ie/privacy-policy