What are the responsibilities and job description for the QA Specialist - CMC position at Talent Group?
Job Description
Title: Senior QA Specialist
Location: Boston, MA - Hybrid
Position Type: Contract
Duration: 6 Months (Possible Extension)
Job Description:
Responsibilities:
- Reviews master batch records and provides customer approval for quality tasks for externally manufactured products.
- 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.
- 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.
Qualifications:
- 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, or relevant comparable background.
- 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 and CAPA
- Experience with network-based applications such as Oracle, Track Wise, Veeva
- Knowledge of current industry trends and ability to use the latest technologies.
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