QUALITY ASSURANCE SPECIALIST
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About the Opportunity
We are looking for a talented individual to fill a Quality Assurance Specialist position at our Ann Arbor, MI facility. The QA Specialist is responsible for developing, coordinating, and maintaining a GMP-compliant Quality Management System throughout the laboratory. This position reports to the Head of the Quality Assurance Unit.
In this position, you will be responsible to:
- Audit and approve project work for compliance with pertinent regulations, Avomeen Policies, and SOPs, and any other client specific requirements.
- Assist in maintaining Avomeen’s document and record control systems.
- Coordinate, develop, review, and revise Avomeen Controlled Documents, including but not limited to Manuals, Policies, Standard Operating Procedures, and Forms.
- Audit laboratory compliance to pertinent controlled documents.
- Assist in managing the laboratory investigation, deviation, CAPA, and Change Control systems, and ensuring laboratory adherence to these systems.
- Develop, coordinate implementation, and monitor a GMP/ISO quality management system throughout the facility.
- Assist in managing the laboratory accreditation applications and renewals including DEA licensing, FDA registration, and ISO 17025 registration.
- Assist in the coordination, performance, and review of internal audits of the laboratory quality program.
- Assist in the development and implementation of the on-going employee training program.
- Assist in responding to regulatory, client, and third party quality assessments.
- Carry out other duties and responsibilities as needed.
- B.S. in a scientific discipline, preferably chemistry
- 3+ years’ experience in a quality role in a cGMP environment as an auditor, coordinator, or manager
- Experience in a contract analytical laboratory setting
- Experience with authoring GMP compliant Standard Operating Procedures
- Experience with FDA and client facility audits
- Experience in Regulatory Affairs
- A highly motivated self-starter that can work with minimal supervision
Why Work for Us?
Avomeen is a full-service laboratory with unique analytical, product testing and formulation development expertise. Each member of the Avomeen team plays a critical and visible role in delivering high-quality scientific solutions, providing them with an opportunity to directly impact Avomeen’s success and advance their career. We make every effort to reward outstanding performance and provide interesting and scientifically challenging work. In order to ensure the success, development, and growth of our employees, we are committed to offering a variety of training opportunities.
Become Part of our Community
We recognize that our single greatest resource is our people, and our team members choose Avomeen not only to join our scientific knowledge-based community, but also to become part of a collaborative team committed to exemplary science and service to our clients. Successful Avomeen employees have a positive, client-centric outlook, and embody principles of integrity and leadership, as well as creativity, flexibility, and perseverance.
Make the most of the hands-on experiences and opportunities Avomeen has to offer.
Ready to Partner? So are We.
Request a quote or ask an experienced scientist today.