Quality Assurance Release Specialist
On-siteRound Rock, Texas, United States
Job Summary
Review and approve batch production records, Certificates of Analysis, and supporting quality documentation prior to product release. Evaluate manufacturing and quality data to identify deviations, trends, and potential risks, then manage investigations related to non-conformance reports, deviations, and CAPA activities. Support change control processes, including quality impact and risk assessments, while ensuring calibration status and GMP requirements remain compliant. Escalate quality or compliance risks that may impact disposition or regulatory compliance. Collaborate cross-functionally with QA, QC, Manufacturing, and Operations to resolve issues, maintain audit-ready records, and support internal and external audits.
Required 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 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
Desired 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
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