Quality Assurance Associate (clean rooms)

CollPlant Biotechnologies is developing technologies in the fields of regenerative medicine, 3D bioprinting of tissues and organs, and medical aesthetics.

We are looking for a talented and highly motivated QA Associate to join our RA/QA department in our manufacturing site in Rehovot.

Job description

• Ensure compliance to QA principles in manufacturing activities
• Support to manufacturing activities in providing on-site appropriate QA guidance to personnel
• Writing and reviewing operational documents (SOPs, Deviations, specifications, etc.)
• Writing and reviewing operation change control
• Train manufacturing employees of procedures, work instructions etc.
• Monitoring aseptic techniques of personnel in clean rooms
• Provide guidance and oversight to manufacturing on-site
• Writing of root cause analysis investigations and execution of CAPAs
• Support validation activities in production
• Reviewing products batch records
• Reviewing and approving calibration reports
• Other duties as assigned by the QA Manager

Job requirements

• 2- 3 years QA experience in a Biotech company with proven knowledge in
• 13485 QMS and GMP Annex I requirements
• Relevant degree (Science, Biology, Biotechnology etc.)
• Experience in cleanrooms
• Experience in aseptic manufacturing process- An advantage
• Good verbal and written communication skills
• Organized, detailed and accountable
• Proficiency in English (writing & speaking)
• Great inter-personal skills

Please send your CV in the attached link https://wkf.ms/3LcuQSP