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Senior QC Associate 30377

  • Job reference: 933547
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 18/01/2021

Orion Group Life Sciences have an exciting opportunity for a QC Associate for our Multinational Biotechnology client based in the South of Dublin area on a 12-month contract.


Job Purpose

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

  • Contributes to team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of milestones associated with specific projects or activities within team

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

Main Responsibilities of the role

  • QC Representative for NPI activities and routine Product meetings
  • Assist with activities related to QC projects and/or QC tasks within Site projects
  • Plan and Perform non-core testing related to NPI activities
  • Manage all sample management activities related to NPI activities throughout the site
  • Create/own and approve protocols, sample plans, SOP and documentation related to NPI
  • Responsible for their own training and safety compliance.
  • Sample shipments and temperature monitoring activities for NPI activities
  • LIMS data coordination of non-core (NPI) activities.
  • With a high degree of technical flexibility, work across diverse areas within QC
  • Plan and perform analyses with great efficiency and accuracy.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Report, evaluate, back-up/archive, trend and approve analytical data.
  • Troubleshoot, solve problems and communicate with stakeholders.
  • Initiate and/or implement changes in controlled documents.
  • May train others as necessary
  • Participate in audits, initiatives and projects that may be departmental or organizational in scope.
  • Write protocols and perform assay validation and equipment qualification/ verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • May contribute to regulatory filings.
  • May conduct lab investigations as necessary.
  • Evaluate lab practices for compliance on a continuous basis.
  • Approve lab results
  • May represent the department/organization on various teams
  • May interact with outside resources.
  • Create APPX data files and randomisation memo to facilitate data analysis.
  • LIMS data coordination of commercial and import testing on site where applicable
  • May provide technical guidance. May contribute to regulatory filings.
  • May represent the department/organization on various teams. May train others.
  • May interact with outside resources

Desired Experience and Background of the successful candidate

  • Bachelor's degree in a science discipline.
    * 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
    * Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information

For more information on this role, call Ian Towler on +353 (0) 212063411 or email Ian.towler@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 933547


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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