Branchburg, New Jersey, 08876
Job description
Quality Specialist
Location: Somerville, NJ
Offer: Competitive Salary and Benefits
The role of the Quality Specialist entails aiding in the development and upkeep of the Quality Management System (QMS) tailored for medical device, pharmaceutical, and combination device sterilization processes. This position involves overseeing the change control procedures, drafting and revising standard operating procedures, administering training programs, managing the approved supplier list, and conducting incoming inspections, all while ensuring adherence to regulatory standards.
Key Responsibilities for Quality Specialist:
- Oversee the change control process which includes preparing ECO documents, updating SOPs, and facilitating the approval of new SOPs.
- Ensure that project deliverables comply with regulatory standards, customer requirements, and relevant FDA regulations (QMSR, CFR 210, CFR 211, ISO 13485, ISO 14971).
- Administer the comprehensive training program across the company.
- Certify and re-certify employees in accordance with company quality policies and procedures.
- Maintain and manage the approved supplier list as well as company distribution protocols.
- Supervise the incoming inspection processes to ensure quality standards are met.
- Meet productivity and quality performance targets while promoting operational excellence.
- Follow all safety protocols, quality standards, and company policies and procedures.
- Carry out all tasks efficiently, safely, and productively.
- Undertake additional responsibilities as needed to align with departmental and organizational goals.
Requirements for Quality Specialist:
- Bachelor’s degree in a relevant scientific field or equivalent professional experience.
- 3 to 7 years of quality assurance experience within a GMP regulated environment, ideally in contract sterilization.
- Strong understanding of cGMP, QMSR, ISO 13485, and ISO 14971 standards.
- Demonstrated professionalism along with outstanding interpersonal and customer service skills.
- Proven ability to manage time effectively while handling multiple priorities at once.
STEMHUNTER is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
