Quality Contract Manufacturing Specialist

25 Apr 2019

Are you a Quality Specialist with business acumen and CMO experience? Are you looking for a more varied role?

Quality Contract Manufacturing Specialist-Biologics-Dublin

Are you a Quality Specialist with business acumen and CMO experience? Are you looking for a more varied role? Would you like to provide information insight and data analysis and drive execution of transactional/tactical tasks to ensure work cell success? If so this may be a great next step in your career.

Key Responsibilities:

Manufacturing operations:

  • Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
  • Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.

Site performance monitoring:

  • Report contract site performance metrics to site lead;
  • Identify improvement opportunities for site performance;
  • Daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams
  • Oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.

Project Management and Technology transfers:

  • Follow-up and track activities in a department-wide project from conception to implementation and close-out.
  • Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

Experience and Qualifications:

  • Bachelor's in Business Administration, Engineering, or Science-related field
  • 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
  • 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
  • 2+ years of project management experience leading multi-functional and/or multi-location team
  • 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
  • Demonstrated competencies of lower GCF levels.
  • Demonstrated matrix management and influencing skills.
  • Manufacturing and cGMP knowledge / experience.
  • Demonstrated negotiation skills.
  • Operational Excellence proficiency and ability to drive continuous improvement.
  • Financial/budgeting knowledge and business acumen.
  • Proficient project management skills.
  • Problem-solving and critical thinking.
  • Understanding of contractual requirements.
  • Technical writing and multi-level communication skills.
  • Demonstrated ability to lead effectively in collaborative/team environment.
  • Demonstrated ability to take initiative, drive action, and work under minimum supervision.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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Fiona Durkin's picture
Senior Consultant | Quality & Validation | Dublin & South East
01 6324650 | fdurkin@morganmckinley.ie