Senior QA Lead: GMP Compliance, Batch Release & Audits

Creative Solutions Services, LLC; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support of manufacturing operations, analytical laboratory operations and materials management for external manufacturing programs at VCGT.

You 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.

Qualifications

• Bachelor's degree in a scientific field or equivalent combination of education and experience.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, root cause analysis and CAPA.

Responsibilities

• Reviews executed 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.
• Ensures presence and acceptability of all required documentation prior to release of the product and/or system.
• Support the day to day management of the batch release process.
• Assist the facility in preparation for quality audits and participate in corporate audits and external inspections as needed.

Skills

Communication

Critical Thinking

Risk Analysis

MS Office

GMP QA

CAPA

Education

Bachelor's degree in science

Tools

Oracle

TrackWise

Veeva

Job description

Creative Solutions Services, LLC is seeking an Operational Area Senior Quality Specialist to provide QA support of manufacturing operations, analytical laboratory operations and materials management for external manufacturing programs at VCGT.

You 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.