Analytical Specialist II

2022-05-18 14:18:532049-11-18Team Horizon
Job TypeContractorFixed Term
Start Date
AdvertiserMary King
Job Ref2473
Job Views174
Team Horizon currently has an exciting opening for Analytical Specialist II to joinour client’s manufacturing facility in Co. Mayo, on an 18month contract.  This role will report the AD of MPS as part of the Pharmaceutical Technology function and will be responsible for various activities. The Analytical Technology Specialist II in the Biologics Development Lab involves undertaking analysis of in-process, release, stability and investigational analytical activities. They are responsible for the completion of write-ups in a timely manner and the review of other analysts work.
The Specialist is involved in supporting and executing Method Transfers, and Validation activities associated with biological drug product
analytical processes. Other aspects of this role are QMS, compiling and review of Laboratory documentation (e.g. SOPs, methods, Master records, Batch Records, Reports) and carrying out routine lab tasks.
What you will be doing:
•    In process, release, stability and investigational analytical activities.
•    Support and execute Method Transfers, and Validation activities.
•    Compiling and review of Laboratory documentation.
•    Carry out training with new members of the group.
•    Support regulatory inspections as required.
•    Perform routine lab tasks to maintain a high standard of housekeeping.
•    Support laboratory projects to ensure timelines are maintained.
•    Ensure all testing is carried out in a timely manner to prevent late testing and delays in manufacturing schedule.
•    Participate at meetings and provide input to key projects to ensure completion.
What you need to apply:

•    Third level qualification in science-based discipline.
•    Lab experience desirable.
•    Good technical writing, communication, time management and organizational skills with a proven ability to use initiative when solving problems.
•    Understanding of GMP and experience with GMP regulatory inspections.
•    Understanding of aseptic practices in clean room environment.
•    Working knowledge of Quality Management System (QMS).
•    Understanding requirements of cross contamination controls in multi-product facility.
•    Experience with commercial and or clinical manufacture. 
•    Experience with interacting in project teams.
•    Flexibility of working hours may be required, and shift work may be required upon request.
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