Quality Control Bioassay Senior Specialist
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities include, but are not limited to:
- Replacing the person managing the Biological Quality Control Team during their absence.
- Conducting biological analyzes using the following methods: ELISA, qPCR, in vitro using cell cultures etc. in accordance with the applicable analytical methods.
- Acting as SME for analytical methods.
- Development and reporting of the results of biological analyzes.
- Verifying the results of biological analyzes performed by other analysts, obtained in Polpharma Biologics and the results provided by external companies.
- Conducting the process of validation and qualification of analytical biological methods.
- Carrying out the process of transferring biological methods to and from external companies and within the organization.
- Creation and updating of analytical methods in the field of QC Bioassay.
- Supporting the process of creating Certificates of Analysis.
- Direct participation in audits and business visits.
- Acting as owner responsible for Quality systems including Change Control and CAPA activities.
- Managing the quality documentation of the Biological Quality Control team.
- Performing and Supervising Data Integrity compliance activities.
- Supervising the training status and supporting the team in the implementation of training and courses.
- Conducting trainings for other team members.
- Performing oversight of processes related to instruments, technical software qualifications and data integrity.
- Cooperation with other departments of Polpharma Biologics.
- Fulfilling the obligations in accordance with the current GMP regulation and other pharmaceutical guidelines.
- Taking care of the laboratory and its contents and keeping it ready for routine activities and audit visits.
- Performing other activities ordered by the supervisor.
If you have:
- Higher education in the field of biology, chemistry, pharmacy, biotechnology.
- Minimum 5 years of experience in laboratory work in regulated laboratory environment.
- Very good knowledge of GLP, GMP and GDP rules.
- Ability to independently solve problems and work in a team.
- Very good knowledge of 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.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more..
