Senior Quality Release Specialist - GMP & Batch Ownership

Creative Solutions Services, LLC; Cambridge (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external manufacturing programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and quality systems documentation for product disposition.

You will lead events investigations, ensure documentation readiness for release, and support audits and external inspections while

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience leading event investigations, RCA and CAPA.

Responsibilities

• Reviews batch records and provides customer approval for QA tasks for externally manufactured products.
• Performs final review of batch and critical systems documentation and determines acceptability per SOPs.
• Ensures presence and acceptability of all required documentation prior to product/system release.
• Support the day-to-day management of the batch release process.
• Assist in preparation for quality audits and participate in corporate/external inspections.
• Communicates with internal and external partners and management.
• Maintains retrievable documentation files.
• Assists with monthly/quarterly Quality System data review metrics and reporting.
• Escalate findings to Quality management and monitor KPIs with Quality Systems.

Skills

QA oversight

GMP

Root Cause Analysis

CAPA

Microsoft Office

Communication

Problem Solving

Risk-based decisions

Event investigations

Quality metrics

Data dashboards

Aseptic processing

Education

Bachelor's degree in science

Tools

Oracle

TrackWise

Veeva

Job description

Creative Solutions Services, LLC seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing operations, analytical labs, and materials management for external manufacturing programs. You will review batch data, deviations, in-process data, EM data, QC release testing, and quality systems documentation for product disposition.

You will lead events investigations, ensure documentation readiness for release, and support audits and external inspections while