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Ref: CCE3296

QC Analyst (Bio) Cork

  • Cork
  • Negotiable
  • Contract
  • Updated 21/04/2017
  • Ann Laide
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Description

QC Analyst required for a start up bio facility to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards. Contact Ann 021 4701100

 

QC Analyst required for a start up bio facility to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards. Contact Ann 021 4701100

Role

  • Analytical and Microbiological testing including but not limited to the following:
  • Microbiological testing performed by the lab incl: EM; Utilities; Bioburden; Endotoxin; Growth Promotion & BIs
  • Anaytical testing performed by the lab incl: HPLC, SDS, FTIR, UV, plate based assays; capillary electrophoresis
  • Testing of finished product, raw materials, packaging and stability
  • Perform primary review of QC raw data and trend results
  • Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
  • Develop, optimize, validate and troubleshoot analytical test methods
  • Draft QC SOPs
  • Act as technical resource (SME)and train other analysts in areas of expertise
  • Evaluate results against defined acceptance criteria
  • Conduct and document laboratory investigations to completion
  • Maintain the laboratory in an inspection-ready state
  • Interact directly with regulatory agency inspectors during audits
  • Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
  • Excellent communication skills both written and verbal
  • Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
  • Self-motivated and ability to work under pressure
  • Team Leadership – active participation team development and continuous improvement including standard work and 5S
  • Successful track record in achieving goals as part of a team within a growing, dynamic environment
  • Demonstrated adaptability and flexibility to support a growing organisation.

 

Education

  • B.S. in a scientific discipline with 3+ years of relevant laboratory experience.
  • Ability to work independently and meeting established timelines.
  • Comfort with coordinating the activities with other staff members. 
  • Comfort with working in a team environment
  • Knowledge of cGMPs.

 

Claran Consultants

Claran Consultants

 

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