Job Title: Quality Assurance Specialist
Reporting to: Senior Quality Assurance Manager
Location: Durham, North Carolina
Pairwise is a mission-driven food+tech company dedicated to building a healthier world through better fruits and vegetables. Founded in 2017 by eminent scientists in the gene editing and biotechnology fields, Pairwise holds licenses from Harvard and Massachusetts General Hospital to base editing and high-fidelity enzymes. We also are tuned in to consumer food trends, and we believe that consumers deserve more variety and innovation in their fresh food choices. Our team is primed to deliver that innovation through one of the best gene-editing platforms in food and agriculture. Pairwise has an exclusive 5-year research collaboration with Bayer to develop products in corn, soybean, wheat, canola, and cotton. Plus, Pairwise is developing new types of leafy greens, berries, and stone fruit, with the first product expected in early 2023. Pairwise is based in the start-up friendly Research Triangle Park area of North Carolina.
About This Role:
Do you have a passion for quality? Well, we sure do! As we grow as an organization, we’re looking to expand our Quality Team with a QA Specialist who is ready to step into a fast-paced, impactful team with a strong desire to grow, show their initiative, and drive the future of our QA function. The role will work closely with a variety of internal stakeholders across our R&D organization to support the on-going development, implementation, and improvement of our Quality Management System (QMS), which is critical to enabling high quality operations within Pairwise. We want someone who loves the details, has experience in quality assurance activities, experience with a QMS within a science-based organization, is motivated by collaboration and finds cross functional collaboration fun. Communication in our kind of company is key, so being able to effectively connect with others will be instrumental to success in this role.
• Provide essential support, training, and guidance on the implementation of our quality management system, with a focus on ensuring compliance and delivering sustainable operations to achieve the highest-level of business performance.
• Contribution to Lean/Six Sigma activities to support ongoing quality plans.
• Act as a valued partner in developing quality goals, objectives and standard operating procedures to validate quality and regulatory compliance.
• Analyze quality KPIs and proactively report areas of concern, drive process improvements.
• Develop and provide training to ensure compliance of company standards, as needed.
• Partner with the rest of the Quality team to develop methods to measure and assess product and process related events.
• Support preparations to ensure successful audits.
• Regularly review current standards and policies and facilitate corrective actions, as needed.
• Act as Document Management System (DMS) administrator to support company document control activities.
• Hybrid work arrangement is expected, with onsite presence at both RTP and downtown Durham offices required.
• Off-site travel on occasion is possible.
Required Education & Experience:
• Bachelor’s degree, or equivalent experience, with 2+ years’ experience in agriculture or related field in Quality, Biotechnology/Regulated/GxP field preferred.
• Highly effective verbal and written communication skills. Strong writing and communication skills for developing and delivering content of audit reports preferred.
• Experience in quality assurance auditing activities including inspection of data and records for completeness and accuracy, conducting on-site audits for traceability and compliance to Pairwise and applicable regulatory standards. Experience auditing in agricultural biotechnology setting preferred.
• Experience with document management systems; including version management and workflows, to obtain company-wide compliance with approved document management processes. Experience with ISO:9001 standards preferred.
• Familiarity with Lean/Six Sigma methodologies.
• Understanding of data analysis, and method/assay validation techniques.
• Competence in IT solutions and modern approaches to Quality Management. Experience in MS Office tools, LIMS, SmartSheet and MS SharePoint experience preferred.
• Record of establishing successful collaborations across teams to support quality culture activities. Proactive approach to collaboratively solving problems in a team setting, including CAPAs, RCAs preferred.
• Agility to work in an evolving technical and innovative field.
• Comprehensive Benefits Plan, including Medical, Dental, Vision, HSA/FSA, 401k, Life Insurance, Short-Term & Long-Term Disability, and more!
• Flexible PTO (use what you need, when you need it), in addition to company holidays.
• Casual work environment.
• Mission-driven organization focused on creating healthier fruits and veggies.
• A cutting-edge, driven community looking to lead the industry in innovation and nutrition.
We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Pairwise we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.