Senior Quality Assurance Specialist II

1 week ago


Allendale, New Jersey, United States Minaris Regenerative Medicine Full time

Estimated Salary: $75,000 - $90,000 per year

Job Overview:

At Minaris Regenerative Medicine, we are committed to advancing cell and gene therapy products. We are seeking a highly skilled Quality Assurance Associate II to join our team. This role plays a crucial part in ensuring the efficient and accurate execution of quality assurance activities.

Key Responsibilities:
  • Document management and review of manufacturing batch records and quality control (QC) data.
  • Facilitating material releases and overseeing final product releases.
  • Providing essential assistance to the Quality Management as needed.
Essential Functions and Responsibilities:

The Quality Assurance Associate II will ensure that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical, and commercial manufacturing. The incumbent must read, understand, and follow all cGMP and cGTP documentation for Quality System Functions (SOPs, WIs, etc.).

  1. Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical, and commercial manufacturing.
  2. Release raw material in ERP system as well as on paper.
  3. Perform Accessioning of incoming Apheresis.
  4. Review Batch record and disposition material of finished product to client.
  5. Provides information for Out of Specification and deviations to investigator.
  6. Performs line clearance prior to manufacturing operations begins.
  7. Supports tech transfer activities.
Qualifications:

The ideal candidate should possess a BS or higher education degree in a scientifically related field. Relevant experience in a biologics or biotechnology company (1-3 years) is required. Working knowledge and technical understanding of the aseptic manufacture of biologics preferred. Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.) is necessary.

Competencies/Candidate Profile:

The successful candidate should have relevant computer skills (Microsoft Office, Outlook). They should be detail-oriented and organized with analytical and problem-solving skills. Good written and oral communication skills are required along with the ability to multi-task and be adaptable. Flexibility and ability to adapt to company growth and evolving responsibilities are also essential.



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