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QC Lead Analyst

2 months ago

Ireland CPL Healthcare Full time

SK biotek Ireland is seeking to recruit a Quality Control Lead Analyst to join the QC Department.

This a fixed term position for 12 months. The position will be reviewed in line with contracts received from customers for analytical services.

Company Overview :

SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to ‘make what matters for a healthy, happier world’, from grams to tonnes. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients and Chemical Intermediates for almost 60 years. With a talented workforce, exceptional technical capabilities, and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at .

Position Description:

  • Perform analysis and analytical review for the Raw Material and API testing groups.
  • Provide technical and compliance support to QC analysts to allow testing requirements to be completed.
  • Work closely with the QC analysts in the team to ensure that this testing is carried out in compliance with local procedures and regulatory requirements.
  • Work to ensure the QC testing metric is met while ensuring manufacturing, stability and shipping timelines are also adhered to.
  • Meet with each team member periodically.
  • Provide ongoing coaching to team members throughout the year
  • Complete performance reviews with team members.
  • Perform weekly approval of direct reports hours of attendance.

Working as part of a Lean Lab team-based structure, the QC Lead analyst should have the following attributes:

  • Ability to lead and motivate people
  • Openness to change, receptive to new ideas
  • Good communication skills
  • Strong technical background in chemistry, particularly analytical chemistry
  • Demonstrated ability to troubleshoot equipment and method issues
  • A methodical approach when investigating issues
  • Knowledge of FDA and European GMP’s, particularly pertaining to laboratory operations.
  • Knowledge / appreciation of other site operations such as QA, R&D, Materials, manufacturing.
  • The desired candidate should be highly motivated, have strong leadership skills, with proven success of leading in a team environment with flexibility to react to changing business needs.

Skills/Qualifications:

  • BSc in Analytical Science, Chemistry or a related discipline
  • Minimum of 3 years’ experience in analytical chemistry
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