Quality Control Bioassay Senior Specialist

As Quality Control Bioassay Senior Specialist you will perform, process, and report  the results of biological analyzes in accordance with applicable procedures and guidelines. We are looking for an experience individual who will be conducting trainings for other team members and serve as a deputy of the line manager of the QC Bioassay Team during his absence.

• Preparation, review and approval of protocols, reports, methods, procedures, instructions and other documents of QC Bioassay
• Performing tests in accordance with approved specifications and methods
• Conducting biological analyzes using the following methods: ELISA, qPCR, in vitro cell cultures, etc. in accordance with the applicable analytical methods
• Supervision over the performance of all necessary tests and evaluation of related records in the QC Bioassay Team
• Supervision, review and approval of the results obtained in Polpharma Biologics as well as the results provided by external companies
• Supervision over the maintenance and qualification of the QC Bioassay laboratory area and equipment
• Participation in internal and external audits
• Fulfilling the obligations in accordance with the current GMP regulation and other pharmaceutical guidelines
• Cooperation with contract laboratories
• Acting as an equipment maintainer of assigned laboratory devices belonging to the QC Bioassay Team
• Informing the supervisor about deviations in the production process and in analyzes carried out by team employees
• Management of the quality records of the QC Bioassay Team
• Planning the work of your own and subordinate employees, as well as reporting the progress of work.

• Higher education in the field of biology, chemistry, pharmacy, biotechnology or 5 years of experience in working in the pharmaceutical industry.
• Minimum 5 years of experience in laboratory work in a regulated environment (preferably in a biotechnology laboratory). Very good knowledge of GLP, GMP and GDP rules.
• Ability to independently solve problems and work in a team.
• Fluency in English language.
• Laboratory precision.
• Analytical thinking.
• Good organization of work and time.
• Very good ability to collaborate with others to solve problems.
• Timeliness, the ability to prioritize tasks.
• Very good knowledge of MS Office.

Important: we offer replacement coctract for 1,5 year