Sr. QA Specialist (External Programs)
6-month contract Boston, MA
*Salary range between $50-55 /hour depending on experience *
The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. 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 in support of product disposition.
- Master's degree with 3-5 years of relevant work experience OR
- Bachelor's degree in a scientific or allied health field with minimum 5 years of relevant work experience.
- Demonstrated success by independently leading cross-functional teams.
- Experience providing QA support and oversight of GMP manufacturing operation.
- Experience successfully leading event investigations, Root Cause Analysis, CAPA, Batch records, change control and variation.
- Experience with network-based applications such as Oracle, TrackWise, Veeva.
- Knowledge of current industry trends and ability to use the latest technologies.
- Knowledge/background with Large Molecules, Biologics, Vial Vector/AV vector, Early phase cell and Gene therapy.
- CMC Chemistry Manufacturing Controls experience.
- 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 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.