Quality Engineer
- Validation Activities: Oversee and execute the primary role and responsibility of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with industry standards and regulatory requirements.
- Quality Assurance Process Design: Design, install, and evaluate quality assurance process sampling systems, procedures, and statistical techniques to ensure compliance and continuous improvement in product quality.
- Inspection and Testing: Design or specify inspection and testing mechanisms and equipment to monitor and assess product quality throughout the manufacturing process.
- Analysis of Production and Service Limitations: Analyze production and service limitations and standards, providing recommendations for improvements and corrective actions to maintain product quality.
- Policy and Procedure Formulation: Recommend revisions of specifications, and help formulate or revise quality assurance policies and procedures to ensure alignment with regulatory requirements and best practices.
- Cross-Functional Collaboration: Interface with all other engineering functions within the organization, including production, R&D, and regulatory affairs, to ensure that quality standards are met at every stage of the manufacturing process.
- Continuous Improvement: Collaborate with management and staff to identify opportunities for continuous improvement in quality systems, process efficiency, and compliance with regulatory standards.
- Other Projects assigned based on business needs
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related field
- Proven experience in quality assurance, validation, or engineering within the pharmaceutical or related industry.
- Strong understanding of pharmaceutical compounding processes, GMP (Good Manufacturing Practice), and regulatory requirements.
- Experience with validation methodologies, including IQ/OQ/PQ, and risk management tools.
- Proficient in designing and analyzing quality systems, statistical techniques, and process improvements.
- Excellent problem-solving, analytical, and communication skills.
- Ability to work in a fast-paced, collaborative environment while maintaining high attention to detail.
- Certification in Quality Engineering (CQE) or similar is a plus.
- Ability to work in an environment that may require standing, sitting, and the occasional lifting of up to [insert weight limit, if applicable].
- Willingness to travel as needed.
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
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