Senior Quality Specialist GMP Batch Release & QA

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC in Wilmington, DE seeks an Operational Area Senior Quality Specialist to provide QA support for GMP manufacturing, analytical labs, and external programs. You will review batch data, deviations, and release documentation to support product disposition.

Responsibilities include batch record reviews, final documentation checks, release readiness, audits support, and data trending.

Qualifications

• Bachelor's degree in a scientific or allied health field or equivalent experience.
• Experience providing QA support and oversight of GMP manufacturing operation.
• Experience leading event investigations, RCA and CAPA.
• Experience with Oracle, TrackWise and Veeva systems.
• Knowledge of current industry trends and ability to use latest technologies.

Responsibilities

• Reviews executed batch records and grants quality task approvals for external products.
• Performs final review of batch and critical systems documentation for acceptability.
• Ensures documentation readiness prior to product/system release.
• Supports day-to-day batch release process management.
• Assists in quality audits and participates in external inspections.
• Communicates with internal and external partners and management.
• Maintains retrievable files and supports monthly/quarterly quality data reviews.
• Escalates major findings to Quality management and tracks KPIs.

Skills

QA oversight

GMP manufacturing

Root Cause Analysis

CAPA

Communication skills

Problem solving

Risk-based decisions

MS Office

Education

Bachelor's degree in a scientific or allied health field

Tools

Oracle

TrackWise

Veeva

Job description

Creative Solutions Services, LLC in Wilmington, DE seeks an Operational Area Senior Quality Specialist to provide QA support for GMP manufacturing, analytical labs, and external programs. You will review batch data, deviations, and release documentation to support product disposition.

Responsibilities include batch record reviews, final documentation checks, release readiness, audits support, and data trending.