Quality Assurance Release Specialist

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

Overview

Reporting to the QA Supervisor, the Quality Assurance Release Specialist is responsible for batch disposition and quality systems oversight to ensure products meet internal, customer, and regulatory requirements prior to release to market. This role applies risk-based decision-making and technical evaluation of manufacturing, quality, and compliance data to support product release, investigation activities, and continuous improvement initiatives.

The position is responsible for managing quality system processes including deviations, non-conformance reports (NCRs), CAPA, and change control, ensuring issues are appropriately investigated, documented, and resolved in accordance with GMP requirements. This role also supports data trending, root cause analysis, and cross-functional quality improvement efforts to strengthen process reliability and compliance readiness.

About Us

Founded in 2010 and based in the Austin area, Goodkind is a leading manufacturer of clean and green personal care and beauty products. Goodkind specializes in natural deodorant, skincare, and facial care products. The company has a wealth of experience in the formulation of these products and can develop according to a variety of guidelines from consumer organizations such as Ecocert to EWG, to retailers such as Credo or Sephora.

Goodkind is a certified B Corporation. As such, we balance purpose and profit, considering the impact of decisions across associates, customers, suppliers, community, and the environment. Goodkind believes by following this central multi-stakeholder approach, we are creating optimal value for each stakeholder while leaving the world a better place.

What You’ll Do

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

What We Require

• 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 working knowledge of GMP requirements and quality systems
• Experience with batch record review and product release activities
• Experience managing deviations, NCRs, CAPA, and change control processes
• Ability to perform root cause investigations and apply risk-based decision-making
• Experience reviewing manufacturing and quality data for compliance and product impact
• Strong written and verbal communication skills
• Strong attention to detail, organization, and documentation practices
• Ability to work independently and manage multiple priorities in a fast-paced environment

Preferred Qualifications

• Experience in OTC, pharmaceutical, cosmetic, or personal care manufacturing
• Experience with ERP systems, eQMS platforms, and Redzone
• Familiarity with FDA regulations, ISO standards, and data integrity principles
• Experience supporting audits, inspections, and validation activities

Key Skills & Competencies

• Batch release and disposition decision-making
• Root cause analysis and risk assessment
• Quality systems management (NCR, CAPA, deviations, change control)
• Data analysis and trend evaluation
• Regulatory compliance and GMP knowledge
• Critical thinking and problem-solving
• Cross-functional collaboration
• Technical documentation and investigation writing
• Accountability and sound judgment