What are the responsibilities and job description for the Quality Systems Specialist position at Etain Health?
About Etain:
Etain is New York's only women-founded, vertically integrated cannabis company with dispensaries in Yonkers, Kingston, Syracuse and a flagship in Midtown East in New York City. Alongside their premium cannabis products, Etain carries a curated selection of women-owned CBD and health and wellness brands to highlight other women in the industry and their products.
Their mantra, "Take a moment with Etain", embodies the spirit and belief that their products meet the needs of our community by delivering the highest quality and purest products, so their patients feel good about investing in their health and wellbeing. They believe the future of cannabis is diverse, and they execute every day on making that future a reality by doing things differently and fostering diversity and inclusion in the cannabis space.
Objective:
Etain, LLC is seeking an experienced Quality Systems Specialist to join our team. As a Quality Systems Specialist, you will play a critical role in development and maintenance of the Etain Quality System.
Essential Functions:
- Oversee internal audit program and perform internal audits
- Oversee Quality-related employee training including developing and conducting training
- Review, edit, and approve controlled documentation in Electronic Document Management System
- Carry out the complaint process including review of complaint information, product review and investigation
- Carry out the CAPA process including assessing risk, identifying root cause, planning CAPA activities, and implementing solutions
- Lead Quality Improvement projects
- Participate in investigations and evaluations to support quality system processes
- Participate in development, implementation, and maintenance of the Quality System
- Monitor changes in regulatory landscape and conduct gap assessments and implementation planning
- Review compliance information to identify potential risks and areas of opportunity
- Prepare for and support audits and inspections
REQUIRED EXPERIENCE, EDUCATION AND SKILLS
- Must be 21 years of age to apply.
- Bachelors Degree and or/Associate's Degree with equivalent experience
- 2-4 years of experience in a quality role in a highly regulated industry
- Prior experience with Good Manufacturing Practices standards in highly regulated industry
- Prior experience with OCM, FDA, Department of Health, or Department of Agriculture regulations
- Ability to follow written procedures and monitor others for adherence to written procedures
- Proficient in Microsoft Office Suite
- Prior experience with Electronic Document Management System preferred
- Certified Quality Auditor / Certified Quality Engineer certifications preferred
- HACCP or PCQI certification preferred
- Experience with root cause analysis tools a plus
Other Duties
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Etain, LLC is an Equal Opportunity Employer and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
