Quality Systems Specialist

2 weeks ago

Dublin, Dublin City, Ireland PE Global (UK) Full time

Description:

PE Global is currently looking for a QC Separations Analyst for a top biotech company in Cork. This is a 12-month contract position.

Overview:

This role involves conducting tasks and projects related to testing procedures, equipment, and lab utilities following Good Manufacturing Practice (GMP) standards. Collaborates with other departments to ensure efficient completion of all QC testing activities.

Responsibilities:

  • Achieve proficiency in laboratory methods for in-process and release testing of biotech products.
  • Review and approve lab test results.
  • Perform analytical testing for method validation and technical transfers meeting ICH, USP, and EP guidelines.
  • Validate, operate, maintain, calibrate, and troubleshoot equipment and associated software.
  • Write and review reports, IQ/OQ, and PQ protocols for equipment qualification.
  • Ensure timely completion, review, and approval of all testing activities.
  • Conduct QC activities in line with product license commitments, cGMP, and company quality standards.
  • Train other QC analysts in lab methods when necessary.
  • Update TMs, SOPs, and WIs as needed.
  • Review and address invalid assays, non-conformances, and deviations.
  • Participate in JSI lean initiatives like Kaizen, 6S, and Gemba.
  • Collaborate with QC group and support group activities.
  • Promptly communicate issues to the QC Team Leader.
  • Stay informed on analytical tech and cGMP standards.

SPECIFIC TESTING EXPERIENCE REQUIRED

  • HPLC
  • Capillary Electrophoresis
  • UPLC/Mass Spec (preferred)

Education and Experience:

  • BSc (Honors) in a scientific/technical field.
  • Minimum 2 years' QC lab-testing experience in bio/pharma industry.
  • Knowledge and experience in an FDA/HPRA approved QC lab.
  • Familiarity with LIMS, Trackwise, and Electronic documentation.
  • Proficiency in Microsoft Office tools.
  • Experience in a high throughput lab setting.
  • Strong technical writing abilities.

Interested candidates can submit a CV for consideration.

Our client does not offer visa sponsorship. Candidates must have the right visa for Ireland.

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