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Cell & Gene Therapy Quality Assurance Analyst

2 months ago

Durham, North Carolina, United States Piper Companies Full time

Piper Companies is currently in search of a Quality Assurance Specialist to become part of a cell and gene therapy organization focused on developing groundbreaking AAV platform products aimed at addressing complex diseases. The Quality Assurance Specialist will play a crucial role in the evaluation and endorsement of data within a GMP framework. This position offers a Monday - Friday, standard working hours schedule and is hybrid.

Key Responsibilities for the Quality Assurance Specialist:

  • Conduct compliance assessments of pharmaceutical manufacturing data across the facility.
  • Engage with cross-functional teams such as manufacturing, process development, and other departments responsible for GMP operations to facilitate the resolution of deviations and compliance issues.
  • Assist in managing CAPAs, Change Controls, Deviations, Out of Specifications, and Laboratory investigation records.
  • Support additional quality initiatives including incoming inspections, material revisions, and project implementations as required.

Qualifications for the Quality Assurance Specialist:

  • Bachelor's degree in a relevant field with 3 - 7 years of quality assurance experience in a GMP setting.
  • Proven experience in QA review and approval of quality system records such as Deviations, CAPA, Change Controls, and Laboratory Investigation Reports.
  • Familiarity with USP, EU, JP, and/or GMP standards.
  • Minimum of 3 years of experience in a pharmaceutical setting, preferably within a cell and gene therapy manufacturing context.

Compensation for the Quality Assurance Specialist:

  • Salary Range: $45 - $65/hr., commensurate with years of relevant industry experience.
  • Comprehensive Benefits: Medical, Dental, Vision, 401k, Paid Time Off.

Keywords: quality assurance, QA, quality control, QC, specialist, laboratory, laboratory data, analytical, analytical development, manufacturing, batch records, cGMP, GMP, compliance, data review, support, laboratory, biologics, small molecule, resolution, deviation, raw materials, improvement, training, mentoring, essential, biopharma.