Quality Assurance Specialist
8 hours ago
We are seeking an experienced Quality Assurance Specialist to join our team at PSC Biotech. This role involves ensuring the highest quality standards in our production and validation processes, implementing process improvements, and conducting thorough investigations, risk management, and corrective action implementation to ensure regulatory compliance.
About the RoleThis is a W2 Temp position that requires strong technical quality, process, and validation expertise. The successful candidate will provide on-the-floor support, monitor and analyze production processes and validation testing to ensure compliance with regulatory requirements, and conduct investigations and root cause analysis to best implement corrective actions for process deviations and quality issues.
Key Responsibilities- Provide technical quality, process, and validation expertise and on-the-floor support.
- Monitor and analyze production processes and validation testing to ensure compliance with regulatory requirements.
- Analyze data from validation tests to determine systems and processes meet required criteria and specifications.
- Conduct investigations and root cause analysis to best implement corrective actions for process deviations and quality issues.
- Provide thorough quality review and approval of required validation lifecycle documentation including commissioning, qualification, validation protocols, reports, records, etc.
- Evaluate non-conformances, perform gap analyses, and take appropriate action to efficiently resolve deficiencies.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3-5 years of proven experience in quality, process, and or validation engineering in the pharmaceutical and/or biotech industry.
- Experience with manufacturing process equipment.
- Strong knowledge of GMP, FDA regulations, and other relevant industry standards.
- Proven success in risk management; experienced conducting non-conformance and deviation investigations and executing CAPA implementation.
- Experience with validation lifecycle management and risk-based approaches.
- Excellent analytical and technical problem-solving skills.
- Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
- Effective communication and interpersonal skills.
- Proactive with strong organization, time management, and project management abilities.
- Excellent attention to detail with commitment to quality and compliance.
- Average salary: $90,000 - $120,000 per year.
The benefits package includes medical and sick time benefits.
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