QC Sample Management & LIMS Coordinator

In this role you will coordinate a group of dedicated specialists, who are responsible for samples management at our production site. It is a great opportunity to build the team from scratch, establish strong relationships and cooperation between diverse departments, and thus to make an important impact on the whole company as well.

• Participation in the launch of new QC lab and formation of a team;
• Coordination of work in reference to receiving and analyses of samples;
• Team and workload management;
• LIMS system development in order to achieve maximum effectiveness;
• Taking care of health & safety on site;
• Taking care of quality of performed tasks and other duties according to set up deadlines, regulations and procedures;
• Supervision of samples registration, gathering and archiving samples,
• Supervision, acceptance and writing of procedures and instructions;
• Management of the process of issuing analytical certificates.
• Stability testing management, development of stability testing programs and results trending.
• Preparation of documentation for registration purposes.
• Cooperation with external laboratories in the field of outsourcing analytical tests.
• Close cooperation with logistics and production area in reference to organization and planning.
• Participation in investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality and other.

• University degree: Chemistry, Biotechnology or equivalent;
• 5 years of working experience in analytical or Quality Control laboratory, pharma or biotech industry;
• Preferred experience in a similar position
• Experience with collection and archiving of samples;
• Good knowledge of LIMS system preferred.
• Practical knowledge regarding conducting stability tests, evaluation of results and their trending.
• Knowledge of GLP, GMP, ICH, FDA, EMEA and/or other local regulations.