Quality Engineer
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Apply Now Application ends in 27d 4h 23min
Job Detail
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Offered Salary 0
Job Description
Your Role
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We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension.We are seeking a highly skilled and detail-oriented Quality Assurance Engineer to join our team in the life science sector. The ideal candidate will have a strong background in quality assurance processes, with specialized experience in auditing, ensuring compliance with regulatory standards, and maintaining the highest quality standards in pharmaceutical production. This individual will play a crucial role in the review and assessment of manufacturing practices, quality control systems, and regulatory compliance within a highly regulated environment.
- Develop, implement, and maintain quality assurance processes and procedures in alignment with industry standards and regulations.
- Ensure all manufacturing processes comply with relevant regulations, including but not limited to FDA, EMA, ICH, and GMP guidelines.
- Review batch records, validation documentation, and quality control data to ensure compliance and product quality.
- Conduct internal and external audits to assess compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards.
- Collaborate with cross-functional teams to ensure effective implementation of audit findings and continuous improvement initiatives.
- Prepare detailed audit reports, CAPA (Corrective and Preventive Actions) reports, and other documentation as required.
- Maintain thorough and accurate records of quality assurance activities, audits, and regulatory communications.
- Participate in the preparation and review of SOPs, work instructions, and other quality-related documents.
- Lead or participate in continuous improvement initiatives, focusing on quality and operational efficiency.
Requirements
- Bachelor’s degree in engineering or related technical field.
- Minimum of 5-7 years of experience in quality assurance within the life science industry.Â
- Proven experience in conducting GMP audits, both internal and external, in a pharmaceutical or life sciences environment.
- Experience with regulatory bodies such as the FDA, EMA, and other international regulatory agencies.
- Familiarity with Quality Management Systems (QMS), CAPA, deviation management, and risk management.
- Strong understanding of GMP regulations, FDA guidelines, and other applicable industry standards.
- Excellent analytical and problem-solving skills.
- Exceptional attention to detail and ability to identify potential areas of risk and non-compliance.
- Strong verbal and written communication skills, with the ability to prepare clear and concise reports.
- Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Apply Now
Application ends in 27d 4h 23min