Quality Assurance Associate

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 engineer to join our RA/QA department in our manufacturing site in Rehovot.

Responsibilities:

• Ensure compliance with 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
• Perform trainings to new employees and maintain on-going trainings and qualification records
• Maintain and File QMS controlled documentation and quality records
• Implementation of ECRs to QMS and distribution of documents to relevant departments
• Coordinate MRBs committees and follow up MRB activities
• Support validation activities in production
• Reviewing and approving calibration reports
• Other duties as assigned by the QA Manager

Qualifications and requirements:

• 2-3 years QA experience in a Biotech company with proven knowledge in ISO 13485 QMS and GMP Annex I requirements.
• Relevant degree (Science, Biology, Biotechnology etc.)
• 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