What are the responsibilities and job description for the Quality Assurance Specialist position at GQR?
Contract QA Specialist
Overview
Clinical-stage biopharmaceutical company seeking an experienced QA Specialist contractor to support GMP quality operations across clinical and commercial manufacturing activities. This individual will play a key role in batch review, material disposition, quality systems management, and cross-functional support for external manufacturing operations.
Key Responsibilities
- Review and approve master and executed batch records for clinical and commercial products.
- Support lot release activities and material disposition decisions.
- Provide quality assessments and oversight for change controls, deviations, investigations, and CAPAs related to drug substance and drug product manufacturing.
- Partner with internal technical teams and external manufacturing organizations to support technology transfer, process validation, and manufacturing readiness activities.
- Support analytical method transfer and validation initiatives.
- Review analytical documentation, stability data, specifications, and related quality records.
- Assist with annual product quality reviews and ongoing quality metrics tracking.
- Maintain GMP documentation and ensure quality records remain inspection-ready within electronic quality systems.
- Provide QA support for product team meetings and communicate timelines related to batch release, investigations, and quality deliverables.
- Contribute to the continuous improvement of internal quality systems, SOPs, and operational processes.
- Support implementation and optimization of electronic quality management systems and related tools.
- Participate in the review and maintenance of quality agreements with external partners and CMOs.
- Support quality review activities associated with regulatory submissions and filings.
Qualifications
- Bachelor’s degree in a scientific discipline such as Chemistry, Biology, or related Life Sciences field.
- 5 years of GMP Quality Assurance experience within the pharmaceutical or biotechnology industry.
- Experience supporting small molecule manufacturing programs preferred.
- Strong working knowledge of GMP regulations, quality systems, and risk-based quality principles.
- Prior experience supporting CMOs and external manufacturing networks.
- Ability to manage multiple priorities in a fast-paced, dynamic environment.
- Strong communication and cross-functional collaboration skills.
- Experience with electronic quality management systems (eQMS) preferred.
- Must be authorized to work in the United States.
Salary : $38 - $48