What are the responsibilities and job description for the Quality Assurance Specialist position at VGXI?
ABOUT VGXI Inc.
VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers.
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.
Summary
This position will primarily be responsible for quality assurance and compliance involving activities related to ensuring that production, testing, and associated documentation meets applicable regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Bachelor's degree from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.
Benefits
At VGXI, we recognize that our employees are at the heart of our success, and we offer exceptional benefits that reflect our commitment to their well-being. Our comprehensive offerings include a range of quality benefits, available to our employees from day one (no waiting period). Benefits include:
At VGXI, we are committed to recognizing and valuing you. Our diverse backgrounds, perspectives, and contributions fuel innovation and allow us to success both as individuals and as a team. We have established and embrace a culture of acceptance and inclusion with equity in recruiting, hiring, developing, and investing in talented people. Our commitment to these principles supports a diverse workforce and empowers us to achieve our mission of leading the industry in producing the next generation of therapeutics to improve patients’ lives.
Equal Opportunity Employer
VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers.
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.
Summary
This position will primarily be responsible for quality assurance and compliance involving activities related to ensuring that production, testing, and associated documentation meets applicable regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Assembling of batch documentation related to disposition products.
- Processing CAPAs.
- Performing routine internal audits of manufacturing and quality control processes.
- Maintaining supplier files.
- Performing supplier audits.
- Maintaining audit files.
- Responsible for proper documentation of equipment.
- Conducting training for new employees.
- Assist in development of quality system SOPs.
- Maintain inventory of products.
- Follow Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
- Work with other departments to solve customer/product issues as necessary.
- Review and approve Certificate of Analysis on finished products, as needed.
- Print and approve product labels based on client / documented requirements.
- Other QA duties as assigned or determined by Area Management
Bachelor's degree from four-year college or university; or three to five years related experience and/or training; or equivalent combination of education and experience.
Benefits
At VGXI, we recognize that our employees are at the heart of our success, and we offer exceptional benefits that reflect our commitment to their well-being. Our comprehensive offerings include a range of quality benefits, available to our employees from day one (no waiting period). Benefits include:
- Medical
- Dental
- Vision
- Life Insurance
- Short-Term and Long-Term Disability
- 401K Plan
- Flexible Spending Account
- Tuition Reimbursement
- Paid Time Off Including Holidays, Vacation and Sick/Personal Leave.
At VGXI, we are committed to recognizing and valuing you. Our diverse backgrounds, perspectives, and contributions fuel innovation and allow us to success both as individuals and as a team. We have established and embrace a culture of acceptance and inclusion with equity in recruiting, hiring, developing, and investing in talented people. Our commitment to these principles supports a diverse workforce and empowers us to achieve our mission of leading the industry in producing the next generation of therapeutics to improve patients’ lives.
Equal Opportunity Employer
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