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QC Associate

  • Job reference: 929069
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 10/12/2019

Orion Group Sciences are looking for a QC Associate for our multinational pharmaceutical client based in the South of Dublin area on an initial 12-month contract with the potential to extend.


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

Main Responsibilities of the role

  • Work with site business owners to provide laboratory business administration, implementation and technical support services for SM-LIMS, Accelrys Smartlab (LMES) and Accelrys CIMS (Inventory Management), Empower
  • 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 requirements in adherence to client 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 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
  • Audit and Inspection preparation and participation

Desired Experience and Background of the successful candidate

  • Hold a third level qualification in a Science related discipline
  • Minimum 4 years' experience in a Biotechnology/ Pharmaceutical/ GMP Environment with previous experience as a user (as a minimum) for LIMS/LMES/CIMS/ Empower
  • Must have previous experience with laboratory software, Knowledge on Data Integrity Assessments (DIA) for computerised systems and execution of CFR 21 Part 11 for computerised systems
  • Familiar with new 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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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