MARS Solutions Group is looking for an experienced Quality Assurance Specialist II Marlborough MA USA. Our client is a leading global Healthcare technologies and digital solutions company with an enduring and innovative presence in the industry. They foster a challenging and empowering environment that cultivates personal and professional growth.
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.
Min of 3-year experience working in a regulated industry
Experience in a pharmaceutical industry
Experience with CAPA systems, Deviations, Non conformance
Experience applying regulations (including FDA cGMP)
Ability to communicate effectively (both written and oral) in English
1. Minimum of 3 years’ experience in a regulated industry is preferred
2. Demonstrated understanding or aptitude to understand Pharmaceutical QMS requirements and regulatory requirements including but not limited to FDA 21CFR 210, 211 and ICH Q10
3. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
4. 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.
5. Demonstrated collaboration, negotiation & conflict resolution skills
6. Excellent communication skills (written & oral)
7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
8. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment
9. Demonstrated understanding of continuous quality/process improvement tools: (As defined by the local site)
10. Experience leading and implementing change
11. Experience performing internal audits and participating in external audits
12. Exceptional analytical, problem solving & root-cause analysis skills
13. Ability to multi-task & handle tasks with competing priorities effectively
14. Strong technical aptitude, global regulatory experience & demonstrated experience interfacing with regulatory.
About MARS Solutions Group:
MARS Solutions Group provides a range of opportunities for meaningful work by understanding that employment fit is a combination of people, process, and technology. We leverage our experienced and compassionate team to bring humanity to matching you with the right advanced technology role, and stay connected with you to help you attain your professional goals.