Quality Assurance and Safety Manager
Fast-paced, early-stage biotech company is seeking a Quality Assurance and Safety Manager to oversee and maintain a Quality Management System (QMS). Ideal candidates will have successfully implemented QMS in a biological research lab and have experience in Pharmaceutical, Food, Agriculture, Fermentation or related industries. Ecovative is an exciting biotech company based in New York. Our founders are TED talk alumni and have been recognized as innovative entrepreneurs on the Forbes 30 Under 30 list. Our work has been featured in The New York Times, Fast Company, Wired, Forbes and on CNN.
This role involves:
Company-wide SOP policy and leadership of SOP development, review and tracking
Company-wide training policy and leadership of training tracking system
Setting, tracking, and enforcing experimental quality and documentation standards
Setting, tracking, and enforcing lab equipment calibration and maintenance schedules
Setting up and maintaining company-wide lot tracking and run tracking systems
Leading the Safety Committee as primary point person on Safety
Establishing bioburden and biohazard risk assessments and policy
Minimum Qualifications and Competencies:
Bachelor’s degree in biological science with a minimum three years’ experience overseeing quality within industrial biological research environment; additional experience will be considered in lieu of education.
This role requires comfort and confidence with communication across departments and leading system improvements coupled with communicating expectations and corrective action items to appropriate team members.
Must have high level computer skills – bring new database and application ideas to Ecovative and adapt quickly to what we have today.
Preferred Qualifications and Competencies:
Experience with QMS, CGMP, and GLP.
Chemistry background, through education or experience.
Familiarity with USDA or FDA regulatory policies.
Knowledge of LEAN and Six Sigma practices.
Experience with quality systems related to new technology documentation, licensing, and technology transfer.
Experience establishing process for maintenance of chemicals inventory, Chemical Hygiene Plan (CHP), chemical and biological (GMO) waste disposal.
Negotiation skills, influential disposition, and dedication toward maintaining a professional and technical knowledge of industry best practices and changes.
Please submit a cover letter along and a resumé, or request an application to Human Resources at firstname.lastname@example.org.
We will review your qualifications and contact you if you are a potential match for the position.
Ecovative is a EEO / AA employer.
What You’ll Love About Us:
Fantastic Team Culture.
Innovative team with diverse interests (from race cars to off-grid living).
Health, dental, vision, retirement, EAP, PTO, tuition reimbursement
Time to Connect.
Earth Day community work, company retreat, holiday events, pie day, costume competitions, pumpkin carving, outings, food, etc.