Quality Analyst Technician
Description
Position and Scope
This role is responsible for conducting Quality Assurance activities, primarily focusing on document control, batch record review, and report writing. Key qualifications include strong technical writing skills and a commitment to continuous improvement. The Quality Assurance Analyst will contribute to Asteria Health’s mission by ensuring compliance and quality excellence. This position reports directly to the Senior Quality Assurance Specialist.
Essential Duties and Responsibilities
- Ensure training documentation for all Asteria personnel is complete and up to date.
- Ensure documentation for group and individual training is assigned as part of change control activities.
- Shadow all departments at Asteria Health to learn tasks and roles. Be able to provide training and qualifications and assist with the development of new training materials as part of continuous improvement.
- Print off and review cleaning logs, equipment logs, and room usage logs.
- Assist the Quality Assurance Specialist with batch record review and communicating any issues to the appropriate personnel.
- Review standard operating procedures and conduct change controls to revise and improve documents as necessary.
- Applies current Good Manufacturing Practice (cGMP) requirements, guidelines and practices.
- Review product labels prior to printing.
- Documentation of minor complaints and deviations.
- Attend all required meetings and provide clear, professional verbal and email communications.
- Complete special projects assigned by Quality Unit such as filing, scanning and data entry.
- Assist the Quality Unit with change control activities.
Skills and Experience Required
- Continued education in science, or similar.
- At least two years (preferred) of practical experience of in a Quality role in an FDA regulated company.
- Experience working with cGMP guidelines and demonstrate expertise in a variety of the field’s concepts, practices, and procedures.
- Experience working with Production or Manufacturing.
- Must exhibit excellent verbal and written communication skills.
- Must exhibit excellent attention to detail.
- Ability to work well independently and in a team environment.
- Good computer skills (data entry, Microsoft Office products, email, internet, eQMS, and inventory management software systems).
- Excellent work ethic.
Additional Notes
- Must be able to gown for ISO 8 area.
- Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.
- Must be able to use necessary equipment such as computers, scanners, phone/headset, or other technological devices as assigned.