Sr Qa Specialist Investigations And Capas Jobs in Massachusetts

Supports the day-to-day management of the batch release process.

Communicates proactively with internal and external partners and management

Master’s degree with 3-5 years or Bachelor’s degree with 5+ years of relevant work experience

Experience providing QA support and oversight of GMP manufacturing operation

Experience with large molecule, biologics, cell/gene therapy, or Vial Vector/AV vectors

Experience successfully leading event investigations, Root Cause Analysis and CAPA

Oversee the management of cGMP training files in the electronic document management system

Business administrator for electronic documentation management systems (Veeva QualityDocs EDMS) and Learning Management System (SuccessFactors LMS)

Identify trends, monitors document control and records performance and metrics, and participates in quality management review (QMR).

Heres What Youll Need (Minimum Qualifications)

Bachelors Degree in Chemistry, Biology or a related scientific discipline, or equivalent work experience

Heres What Youll Bring to the Table (Preferred Qualifications)