Quality Assurance Release Specialist
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
