Trumbull, United States
about 2 months ago
For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial.
Lighthouse Professional Services committed to the success of the companies, candidates and employees we serve. We invest in excellent working partnerships, powered by people.
We are currently seeking a Quality Assurance Analyst in Livingston, NJ.
Position Summary and Special Duties:
As a (an) Quality Assurance Analyst your day to day duties will consist of and may not be limited to: The Quality Assurance Analyst assumes responsibility for establishing Quality Management System processes and procedures in preparation for ISO 15189 accreditation. The position will support all project goals, objectives and deliverables including but not limited to employing a risk-based approach for addressing procedural gaps in processes, working to engage lab operations and other departments in adopting ISO 15189 compliant processes and practices and reinforcing compliance to new and streamlined processes implemented.
In this role, the Quality Engineer shall partner with the project’s team members and impacted functional units to ensure that project tasks and deliverables are completed on time and sustainably.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Perform process mapping of core Quality Management System processes. Facilitate the process mapping of pre-examination, examination, and post-examination processes.
- Identify gaps from process mapping sessions and develop solutions to address gaps.
- Write, review and/or process Standard Operating Procedures.
- Write, review and/or process knowledge and competency assessments.
- Organize and/or ensure that knowledge and competency assessment records are completed on time.
- Assist and/or lead internal audits and write audit reports.
- Assist with the development, writing and/or implementation of corrective and/or preventive actions (CAPA) resulting from internal audits.
- Monitor the progress of project activities by ensuring that the status of project tasks is reflected accurately in the project plan.
- Actively support with inspection readiness planning, record review and logistics.
- 5 years+ Quality and Regulatory experience in medical device, pharmaceutical / biotech industry.
- 3+ experience in conducting internal audits and implementing CAPA.
- Knowledge of applicable regulatory requirements including ISO 15189, ISO 13485, 21 CFR Part 820 Quality System Regulation.
- Technical writing experience; creation and review of Standard Operating Procedures.
- Experience in the development or roll out of Quality Management Systems.
- Solid communication and interpersonal skills. Ability to influence functional areas in adopting new processes.
- Advanced skills with Microsoft Office Suite and team collaboration tools such as SharePoint, SmartSheet and BOX.
- Bachelor's Degree in life science or pharmacy required.
- May consider other combinations of experience and education, if appropriate.
Duration: 8 months temp to permanent.
Hours: Office: 8:30AM- 5PM
Location: Livingston, NJ.
Salary: depending on experience
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.
Submit resumes to: firstname.lastname@example.org