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Harba Solutions

Quality Assurance Analyst II

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Job Description

Overview We are seeking a detail-oriented Quality Assurance Analyst to support quality and product release activities within a regulated manufacturing environment. This position will focus on reviewing quality documentation, supporting product release decisions, maintaining compliance with quality standards, and working with cross-functional teams to resolve quality-related issues. The ideal candidate has experience working in a regulated environment, strong attention to detail, and the ability to manage multiple priorities while maintaining high standards for quality and compliance. Responsibilities Review and audit manufacturing, batch, and quality records for accuracy and compliance. Support product release and disposition activities for materials and finished products. Review deviations, nonconformances, and other quality records throughout the product lifecycle. Work with Operations and other departments to resolve documentation and compliance issues. Identify opportunities to improve quality processes, procedures, and overall efficiency. Assist with quality metrics, reporting, and continuous improvement initiatives. Provide support and guidance on quality-related questions and documentation. Participate in training and cross-functional quality initiatives as needed. Qualifications Bachelor's degree in a scientific discipline or equivalent relevant experience. At least 2 years of professional experience, preferably in a regulated manufacturing, pharmaceutical, biotechnology, medical device, or similar environment. Working knowledge of c
GMP, FDA
regulations, ISO standards, and quality systems . Strong documentation review, auditing, and attention-to-detail skills. Ability to work independently while managing multiple priorities in a fast-paced environment. Strong written and verbal communication skills. Proficiency with Microsoft Office applications. Experience with ERP or electronic document management systems is a plus. Strong organizational and teamwork skills with a commitment to maintaining quality and compliance.
Pay:
$30.00 - $35.00 per hour Expected hours: 25.0 - 30.0 per week
Work Location:
In person