QA Release Lead: Batch Release & Compliance

The Goodkind Co; Round Rock (TX); On-site; USD 75,000 - 115,000; Full time

Job summary

The Goodkind Co seeks a Quality Assurance Release Specialist to ensure products meet regulatory and internal standards before market release. You will review batch records, assess data for quality risks, and support investigations, CAPA, and change control to improve reliability and compliance.

Ideal candidates have 3+ years in QA within regulated manufacturing, strong GMP knowledge, and experience with batch records, NCRs, CAPA, and data trending.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, Life Sciences, or related field (or equivalent experience).
• 3+ years of Quality Assurance experience in a regulated manufacturing environment.
• Strong GMP knowledge and quality systems experience.
• Experience with batch record review and product release activities.
• Experience managing deviations, NCRs, CAPA, and change control processes.

Responsibilities

• Review and approve batch production records and related quality documentation prior to release.
• Evaluate manufacturing and quality data to identify deviations, trends, and risks to product quality.
• Lead investigations for NCRs, deviations, and CAPA activities; perform risk-based assessments.
• Support change control processes including quality impact assessments.
• Review COAs and product specs for release approval; ensure calibration and quality-system readiness.

Skills

Batch release

Root cause analysis

GMP knowledge

Risk assessment

Cross-functional collaboration

Investigation writing

Quality documentation

Education

Bachelor's degree in Chemistry, Biology, Engineering, Life Sciences, or related field

Tools

ERP systems

eQMS platforms

Redzone

Job description

The Goodkind Co seeks a Quality Assurance Release Specialist to ensure products meet regulatory and internal standards before market release. You will review batch records, assess data for quality risks, and support investigations, CAPA, and change control to improve reliability and compliance.

Ideal candidates have 3+ years in QA within regulated manufacturing, strong GMP knowledge, and experience with batch records, NCRs, CAPA, and data trending.