GMP Batch Release & Quality Assurance Lead

The Goodkind Co, a Certified B-Corp; Round Rock (TX); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Goodkind, based in the Austin area, seeks a Quality Assurance Release Specialist responsible for batch disposition and quality system oversight to ensure products meet GMP and regulatory standards before market release.

The role involves risk-based decision-making, data evaluation, NCR/CAPA management, and cross-functional collaboration to strengthen process reliability and compliance readiness. Experience in OTC/personal care manufacturing is a plus.

Qualifikationen

• Bachelor's degree or equivalent experience in a related field.
• 3+ years of QA experience in a regulated manufacturing environment.
• Experience with GMP requirements and quality systems.

Aufgaben

• Review and approve batch production records and supporting quality documentation prior to product release.
• Evaluate manufacturing and quality data to identify deviations, trends, and quality risks.
• Manage investigations related to NCRs, deviations, and CAPA activities.
• Support change control processes, including quality impact and risk assessments.
• Review COAs and product specifications for release approval.
• Ensure calibration status and related quality system requirements are compliant before batch disposition.
• Analyze and trend quality data to identify recurring issues and support improvement.
• Escalate risks that may impact product disposition or regulatory compliance.
• Collaborate cross-functionally with QA, QC, Manufacturing, and Operations to resolve quality issues.
• Maintain audit-ready quality records and documentation.
• Support internal and regulatory audits and inspections.
• Perform additional duties as assigned.

Kenntnisse

Batch release & disposition

Root cause analysis

Quality systems management

Data analysis

Regulatory compliance & GMP knowledge

Cross-functional collaboration

Technical documentation

Investigation writing

Accountability & judgment

Ausbildung

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

Tools

ERP systems

eQMS platforms

Redzone

Jobbeschreibung

Goodkind, based in the Austin area, seeks a Quality Assurance Release Specialist responsible for batch disposition and quality system oversight to ensure products meet GMP and regulatory standards before market release.

The role involves risk-based decision-making, data evaluation, NCR/CAPA management, and cross-functional collaboration to strengthen process reliability and compliance readiness. Experience in OTC/personal care manufacturing is a plus.