Type: Salaried, Exempt
Quality Assurance Specialist I/II/III reports to the Manager, Regulatory and Quality and is responsible for Quality Assurance (QA) activities at Lacerta Therapeutics, Inc. including the responsibilities listed below. This Job posting is open to entry level applicants (Quality Assurance Specialist I) and those with relevant industry experience (Quality Assurance Specialist II or III).
- Reviews and/or approves standard operating procedures, material and product specifications, test methods, work instructions, forms and master batch records
- Support pre-clinical and clinical project teams as the QA subject matter expert
- Review pre-clinical and process development reports for regulatory submissions
- Provides oversight of technology transfer activities
- Provide QA oversight internal and outsourced CGMP activities
- Support the Regulatory Affairs team with regulatory submissions as needed
- Bachelor’s degree required, preferably in a scientific discipline
- Proficient with Microsoft Word, Excel and Project
- Experience in gene therapy, biologics or pharmaceutical Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing or Product Development
- Experience and proficiency with FDA compliant software systems for CGMP compliance
- 2-5 years’ experience in FDA regulated industry
- Working knowledge of FDA regulations including CGMPs, GLPs and GCPs
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is continuously required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and stoop, kneel, or crouch. The employee must regularly lift and/or move up to 15 pounds and occasionally lift/or move up to 40 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and the ability to adjust focus.
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.