This position is primarily responsible for management of Quality audits and supplier qualification at Synthego but will provide support to other Compliance and Quality Assurance areas, as needed. The ideal candidate will be responsible for managing logistics of external and internal audits, capturing metrics relating to audits, and representing the Quality Assurance team in audit
correspondence and in-person engagement with auditors. This position is also responsible for supplier qualification program and working closely with internal functions to promote continuous improvement and quality excellence.
About You:
- Bachelor’s degree in science field (Chemistry, Biochemistry, Microbiology) or Engineering
- 2+ years in Quality Assurance; or experience working in a cGMP regulated environment with positions of progressive responsibility.
- Expertise in Quality Management Systems and Good Manufacturing Practices
- Overall understanding of audit role within Quality Assurance and implications of audit performance on business outcomes.
- Ability to communicate and work cross functionally with other teams.
- Ability to influence in a team environment and collaborate with peers.
- Performance-focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.
- High level of personal motivation and initiative, and ability to work independently on projects.
- Excellent written and verbal communication skills.
- Attention to detail, safety, quality and customer requirements.
- Proficiency with MS Office and GSuite products.
What You'll Do:
- Support internal, client, and regulatory audits/inspections as required:
- Prepare for audits: take ownership of audit preparation activity, including site-visit logistics
- Participate in audits: represent Quality Assurance team accurately and fairly in audit settings; provide documentation support for requested materials; support internal audits to evaluate the effectiveness of Synthego’s quality management systems, processes, and standards
- Report findings: prepare detailed audit responses to audit reports, inclusive of relevant action plans; respond to auditors in a timely manner; and track for completion of corrective/preventative actions
- Analyze data: collect and analyze metrics from audits to identify trends, risks and opportunities for improvement and report metrics in Management Review
- Documentation: maintain accurate and comprehensive records of audits, related documentation, and corrective actions. Ensure documentation is accessible and current Risk Management: identify potential risks related to quality and compliance; contribute to development of strategies to mitigate risks
- Continuous Improvement: continue to build on professional concepts toward culture of quality in compliance with ISO 9001:2015 QMS standards and FDA regulations
- Supplier Management: qualification and monitoring of suppliers and supplier actions (SCAR)
- Provide Quality Assurance oversight for all INDe/GMP activities, including Supply Chain, Facility, Factory Service Engineering, QC, Manufacturing Operations, for conformance to GMP requirements
- Participate in authoring or revising Standard Operating Procedures (SOPs) to ensure compliance to 21 CFR Parts 11, 210, and 211, ICH Q7, ICH Q10.
- In addition to support audit activities, Quality Audit Specialist will support other Quality activities such as quality management review, training program, document control, raw materials inspection and disposition, area approval, authorship, review and approval of quality events (non-conformance, change controls, CAPA, complaints) and procedures.
Company Perks & Benefits
- Equity options
- Medical, dental, and vision benefits
- 401k Program
- Catered meals on Tuesday and Thursday
- Paid parental leave
- Flexible paid time off
About Us
Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
Based on a foundation of engineering and chemistry, Synthego leverages automation and machine learning to synthesize high-quality CRISPR reagents for science at scale. Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.
With its technologies cited in hundreds of peer-reviewed publications and utilized by thousands of commercial and academic researchers and therapeutic drug developers, Synthego is at the forefront of innovation, enabling the next generation of medicines by delivering genome editing at an unprecedented scale.
What We Do
Synthego is a genome engineering company enabling the acceleration of life science research and development in the pursuit of improved human health.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. By vertically integrating hardware, software, bioinformatics, chemistry, and molecular biology, Synthego is at the forefront of innovation advancing the next generation of medicines through providing access to genome editing at an unprecedented scale.
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Our Culture of Diversity: Different Faces from Different Places
At Synthego, our differences make us unique, help us innovate, and allow us to persevere. We stand firmly behind our values, strive to achieve representation, and celebrate diversity in perspectives and backgrounds. We welcome all team members to be their best selves as we move forward towards fulfilling our shared vision of revolutionizing genome engineering technology to help make biological therapies accessible to all patients.
