Snr QC Associate - NPI

Competitive
Permanent
Dublin
16 Jan 2020
BBBH750941

Senior QC associate required for an NPI team in a global Biopharma.

Primary Responsibilities

  • 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.
  • 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 method 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.

Knowledge:

  • 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
  • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues

Relevant experience:

  • Bachelor's degree in a Science related field is required.
  • 2-5 years of bio/pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Aoife Duggan's picture
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