Salary Range: 85000 to 110000 (Currency: USD) (Pay period: per-year-salary)

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