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Quality Control Specialist in Gene Therapy
2 months ago
Piper Companies is currently in search of a Quality Assurance Specialist to become a part of a cell and gene therapy organization that is pioneering advanced 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 setting. This position operates on a Monday to Friday schedule and offers a hybrid work model.
Key Responsibilities:
- Conduct compliance assessments of pharmaceutical manufacturing data across the facility.
- Engage with cross-functional teams, including manufacturing and process development, to facilitate the resolution of deviations and compliance issues.
- Assist in the management of CAPAs, Change Controls, Deviations, Out of Specifications, and Laboratory Investigation Records.
- Support various quality assurance functions such as incoming inspections, material revisions, and project implementations as needed.
Qualifications:
- Bachelor's degree in a relevant field with 3 to 7 years of quality assurance experience in a GMP environment.
- Proven experience in the review and approval of quality system records, including Deviations, CAPA, Change Controls, and Laboratory Investigation Records.
- Familiarity with USP, EU, JP, and/or GMP regulations.
- A minimum of 3 years of experience within a pharmaceutical organization, preferably in a cell and gene therapy manufacturing context.
Compensation:
- Salary Range: $45 - $65 per hour, commensurate with 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.
