Senior Associate QC

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

•This job specification outlines the general responsibilities associated with the role of CW Senior Associate for the International Analytical Support function.
•This role will be responsible for coordinating, facilitating, and undertaking activities pertaining to transfer of analytical methods to international government / contract labs as part of Amgen's global sales expansion.
•The role also represents the QC unit by liaising with internal and external customers.
•Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.
• Supporting Amgen drug product analytical method transfers to international government / contract labs as part of Amgen's global sales expansion.
• Management of various aspects of the analytical method transfer process (e.g. tracking of transfer milestones, preparation and approval of analytical method transfer plans and reports and ensuring adherence to transfer requirements).
• Completing subject matter expert data review of International lab method run results where required.
• Providing analytical support for drug product registration/import testing in International labs, through management of the shipment of Amgen reference standards, critical reagent and commercial materials.
• Working collaboratively with other functions within the Amgen network and international labs (e.g. International Quality, Regulatory, Supply Chain and Logistics).
• Support the management team with the visual management board and tracking KPIs for the IAS group.
• Competent in the use of document management systems such as EDMQ/CDOCS

Education & Experience

• Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology or Biotechnology.
• Have at least 2 years relevant experience in a pharmaceutical/healthcare environment.
• Be very proficient in the use of Microsoft Word, Excel etc.
• Have strong technical writing skills.
• Be detail oriented, self motivated with good troubleshooting and problem solving abilities.
• Be a self starter and capable of working on own initiative.
• Strong team work skills.
• Proven track record of meeting deadlines.
• Experience with analytical techniques such as HPLC, Bioassay and Compendial testing would also be advantageous