QC Associate Scientist

Location: Stein
Duration: Until 31st January 2021

Job Title: QC Associate Scientist
Department: Cell and Gene Bioanalytics

Job Purpose:
Under general direction, perform testing and other activities in functions supporting the Bioanalytics department.

Major Accountabilities:
• Plan and perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, re-sidual bead assessment, qPCR, Potency, in collaboration with experienced team members, if necessary.
• Perform all testing and activities compliantly following appropriate SOPs and proce-dures.
• Maintain controls, reagents and reference standards to support testing.
• Work on shifts covering daytime / evening and one or both weekend days.
• Review data generated by other team members.
• Train others.
• Contributes to the setup and optimization of infrastructure or specialized facilities e.g. cell culture or qPCR labs as an expert w/ adequate guidance.
• Evaluate/qualify and maintain lab equipment.
• Execute validation/transfers/optimization of test methods as per appropriate protocols.
• Contribute to OOS/OOE and deviation investigations.
• Interface with regulatory agencies during audits.
• Support 5S and Lean projects.
• Continually identify areas for improvements in project work.
• Knowledge of LabWare LIMS and/or other QC data systems.
• Maintain GMP/GLP quality systems.
• Review of laboratory logbooks and laboratory cleaning.
• Performing daily equipment startup and PQ
• Assure stock of reagents and materials

Education:
Commercial degree as BTA or MTA or BSc degree (candidates with an MSc degree might get considered also) in biology, chemistry, biochemistry, microbiology or other related discipline

Languges: Fluent in Englisch is a must, Fluency in German is advantageous

Professional experience and competencies:

o 2-5 years (for candidates with a Masters degree 0-2 years) industry working experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
o Understanding of the concepts of GMP and GLP
o Knowledge of bioassay test methods like Cell counts, Elisa, Flow cytometry.
o Ability to communicate clearly with a variety of individuals in various aspects of operations.
o Strong written and verbal communication skills are essential.
o Ensure customer satisfaction and react to customer requests
o Strong ability to work independently, compliantly and results driven.
o Pays attention to detail
o Able to proof work and identify non-standard format or wording, and errors within documents