Laboratory Quality Assistant
The Assistant QA will work with other staff to ensure policies, procedures, and products adhere to established quality standards and maintain regulatory compliance. The QA Assistant will be highly involved in the preparation and completion of external and internal quality audits and risk assessments. The QA Assistant will provide support in activities including, but not limited to, event management, document and records management, audit management, licensure and accreditation, and sample management. The QA Assistant will also participate in and support the company’s continuous improvement. This is a full-time position. Combination of remote and on premise in the Framingham location.
- Write, maintain, and update Policies and Procedures across company processes.
- Manage and update tracking databases for various processes and quality indicators.
- Create analytical reports of quality indicators.
- Assist with investigation of nonconforming events (NCEs) and Corrective and Preventive Actions (CAPAs).
- Assist in all aspects of proficiency testing programs, completing documentation for submission, storing and maintaining PT records, and trending PT performance data.
- Record Review appropriate documentation of all QC/QA standards, such as validations, failed run logs, training and competency assessments, continuing education, preventative maintenance/function checks, etc. Ensures records are maintained as specified by regulatory guidelines.
- Participate in the preparation for internal and external audits
- Participate in the periodic internal and external audits and inspections.
- Participate in the preparation of audit reports and inspection observations.
- Participate with compilation of audit findings.
- Maintain current and accurate quality management records.
- Assist with planning validation protocols/studies and preparing validation packages for submission.
- Perform, monitor, and track calibrations, verifications, maintenance, and troubleshooting on laboratory equipment to assure that quality system requirements are met or exceeded.
- Managing inventory of laboratory consumables, reagents, and equipment calibration schedules.
- Assist in new employee onboarding (example: color discrimination test).
- Support, maintain and continually improve Quality Management System.
- Additional tasks as needed.
- BSc in sciences or related fields.
- 1+ years in Quality Assurance preferred.
- Scientific background in molecular biology and/or NGS an advantage.
- Analytical thinking with superb attention to detail.
- Excellent oral and written communication skills.
- Experience or familiarity with diagnostics or clinical lab operations is an advantage.
- Familiarity with QA activities across multiple quality systems (e.g. HIPAA, CLIA/CAP).
- Ability to work well under pressure while maintaining a professional demeanor.
- Excellent interpersonal skills.
- Excellent computer skills.
- Must be able to organize and handle multiple tasks.
- Must be a self-starter with a high level of initiative.
To apply for this job email your details to email@example.com