QC Specialist - New Product Introduction & External Testing

Morgan McKinley View all jobs

  • Carlow
  • Contract
  • Full-time
  • 9 days ago
11 month contract roleBased in CarlowHybrid - minimum 2 days on siteA leading biopharmaceutical manufacturing site is seeking a QC Specialist - NPI & Network Testing to join its Quality Control team. This role will be part of an integrated function supporting new product introductions (NPI) and network testing activities, driving quality, compliance, and operational excellence across internal and external laboratory networks.Key Responsibilities:
  • Lead QC activities related to new product introductions and network testing, including demand planning, cross-site coordination, and implementation of testing strategies in line with regulatory expectations
  • Collaborate with internal teams and external partners to ensure compliant and efficient execution of testing activities
  • Coordinate testing across internal laboratories and external contract testing organisations, including investigation of OOS/OOT results and communication with project teams
  • Maintain sample management and reporting processes, ensuring associated systems (e.g. LIMS, SAP) support operational needs
  • Manage deviations, investigations, and change controls, while maintaining GMP documentation such as SOPs and system updates
  • Support annual product reviews and documentation for regulatory submissions and product lifecycle changes
  • Assess the impact of pharmacopeial and quality standard updates on testing requirements
  • Lead and contribute to continuous improvement initiatives and operational excellence projects
Requirements:
  • 3-5 years' experience in a pharmaceutical or biopharmaceutical QC environment
  • Degree in Science, Engineering, or a related discipline
  • Strong understanding of cGMP and laboratory quality systems
  • Knowledge of regulatory requirements related to laboratory testing
  • Experience with electronic systems (e.g. LIMS, SAP or similar)
  • Proven experience in technical writing, including reports, procedures, and policies
  • Ability to work independently and manage priorities effectively
  • Strong communication and cross-functional collaboration skills
  • Experience with Lean tools (e.g. process mapping, problem solving, 5S, continuous improvement methodologies) is advantageous
This is a hybrid role offering the opportunity to work within a collaborative and high-performing environment, supporting innovative products across a global network.

Morgan McKinley