Quality Assurance Specialist

Industry:
Healthcare
Type:
Contract
Location:
Marlborough, MA
Job ID:
#166586

Our Global Life Sciences client is currently looking for a Quality Assurance Analyst who will be responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices in Marlborough, MA.

We at Ian Martin envision a world where everyone is connected in meaningful work and if you find great meaning in developing some of the most widely used products in the world, then we have the career path for you.

Role Summary/Purpose

This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service.

Qualifications/Requirements

·        Min of 3-year experience working in a regulated industry

·        Experience in a pharmaceutical industry

·        Experience with CAPA systems, Deviations, Nonconformance

·        Experience applying regulations (including FDA cGMP)

·        Ability to communicate effectively (both written and oral) in English

Desired Characteristics

·        Minimum of 3 years’ experience in a regulated industry is preferred

·        Demonstrated understanding or aptitude to understand Pharmaceutical QMS requirements and regulatory requirements including but not limited to FDA 21CFR 210, 211 and ICH Q10

·        Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

·        Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls;

·        Corrective & Preventative Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

·        Demonstrated collaboration, negotiation & conflict resolution skills

Looking for Meaningful Work? We can help.

If you are a Quality Assurance Analyst, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.

We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at recruit@ianmartin.com.

We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.