Quality Assurance Associate II – Allendale, NJ
Our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies, and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
The Quality Assurance Associate plays a pivotal role in ensuring that all quality assurance activities are conducted efficiently and accurately. Under direct supervision, the associate supports daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures. Key responsibilities include document management, review of manufacturing batch records, quality control (QC) data, facilitating material releases, overseeing final product releases, and providing essential assistance to the Quality Management as needed.
Essential Functions and Responsibilities:
• Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
• Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)
• Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
• Release raw material in ERP system as well as on paper.
• Perform Accessioning of incoming Apheresis.
• Review Batch record and disposition material of finished product to client.
• Provides information for Out of Specification and deviations to investigator.
• Performs line clearance prior to manufacturing operations begins.
• Supports tech transfer activities.
• Other duties as assigned.
Qualifications:
• BS or higher education degree in a scientific related field
• Experience in a biologics or biotechnology company (1-3 years)
• Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
• Working knowledge of GMP and TCTP regulations
• Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)
• Must be able to gown up and go into a cleanroom
Competencies/candidate profile:
• Relevant computer skills (Microsoft office, outlook)
• Detail-oriented and organized
• Analytical and problem-solving skills
• Good written and oral communication skills
• Ability to work independently and within a team