Company Overview
EMMA International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Bingham Farms, Michigan. We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.
Position Summary
The QA Specialist will be responsible for the development, maintenance, and implementation of specifications and standards for materials and products in accordance with quality programs, plans, SOPs, and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable. The individual will interact with clients to ensure the timely preparation of organized and scientifically valid applications to regulatory bodies.
Essential Duties
- Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other international regulations as applicable.
- Participate in projects directed at the development and implementation of quality standards throughout the company.
- Participate in department meetings to provide input into the design and implementation of product specifications.
- Write, review, and edit documents and SOPs as required.
- Assist in validation activities and development of requirements and specifications.
- Facilitate problem-solving activities, team building and quality systems tools and methodologies.
- Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
- Act as a liaison between clients and regulatory authorities regarding submissions.
- Interpret statutes, regulations, policies and guidance documents for business teams and product development/support teams, communicating how these impact product development, manufacturing, and/or marketing.
- Remain current on regulatory issues/trends affecting business unit products, assessing, and communicating their impact to regulatory affairs colleagues, product development/support teams, and to others in the business.
- Maintain departmental Standard Operating Procedures (SOPs).
- Work on client related regulatory submissions.
- Other duties as assigned.
Qualifications
- 1-2 years’ experience in the life science industry
- The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills, and experience.
- Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.
- Past experience in quality or regulatory science preferred
Education
Bachelor’s degree in a health/life sciences discipline required.
Working Conditions
- The work will be performed in an office environment.
- Minimal physical effort will be required in this position.
- Workdays: Monday – Friday, 8:00am – 5:00pm