Senior Quality Assurance Specialist
3 days ago
Job Summary:
The Senior Quality Assurance Specialist will provide critical support to Vertex's manufacturing operations, analytical laboratory operations, and materials management for external manufacturing programs. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation as needed to ensure product disposition.
Key Responsibilities:
- Reviews master batch records and provides customer approval for quality tasks for externally manufactured products.
- Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures.
- Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
- Reviews and approves investigations, CAPA's, and change controls for external programs.
- Supports the day-to-day management of the batch release process.
- Supports annual product quality reviews.
- Assists the facility in preparation for quality audits and participates in corporate audits and external inspections as needed.
- Communicates proactively with internal and external partners and management.
- Maintains files such that documents are readily available and easily retrievable.
- Assists the department with monthly/quarterly Quality System data review metrics and reporting.
- Escalates critical and major findings to Quality management and monitors key performance indicators in collaboration with Quality Systems and other GXP Operational areas.
Requirements:
- Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.
- Experience providing QA support and oversight of GMP manufacturing operations.
- Experience successfully leading event investigations, Root Cause Analysis, and CAPA.
- Experience with network-based applications such as Oracle, Veeva.
- Knowledge of current industry trends and ability to use the latest technologies.
Work Environment:
This is an on-site designated role, requiring five days per week on-site work with ad hoc flexibility.
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