Position located in Boston, MA

Responsibilities of the Quality Specialist (CDMO):

• Generation, review and maintenance of Quality System documentation and procedures.
• Assure compliance of processes and documentation with cGMP standards.
• Provision of suggestions and comments, evaluation and approval of changes directly related to the critical systems, manufacture and analytical methods.
• Review of standard operating procedures.
• Review of GMP related documents, such as specifications, methods, validation documents, technology transfer documents, etc.
• Issue approved hard copy documents to designated departments.

Requirements of the Quality Specialist (CDMO):

• BS degree in life sciences and 2+ years relevant quality experience.
• Previous work experience in quality assurance, quality control or production.
• Work experience in a CMO/CDMO would be an advantage.
• Very good computer skills.