We're looking for a Quality Assurance Specialist, working in the Biotechnology/Medical Devices industry in Gaithersburg, Maryland, United States.
Implements, manages, audits and maintains the client's quality systems.
Ensures quality systems conform to regulations and quality policies.
Implements Quality Systems governance for Deviations, CAPAs, Change Control, and Internal Auditing.
Supports deviation system and ensure proper investigation and root cause analysis are performed and corrective actions implemented.
Supports the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
Conducts effective root cause analysis and implements corrective action and preventative action.
Supports quality assessments of internal operations to analyze compliance and assess risk.
Reviews and approves proposed changes to systems, procedures and methods.
Reviews and approves deviations, LIRs, OOS, in compliance with SOPs and timelines.
Implements, manages, and performs Internal Audit Program at the client's facility.
Supports all site’s client audits and regulatory inspections.
Supports New Hire Orientation and Train-the-Trainer training content and delivery.
Supports, develops, and delivers technical and/or compliance training to clinical site staff.
Supports tracking and communication of site metrics to management.
Reviews and approves training procedures, which include, but are not limited to: SOP's, controlled forms, and work instructions.
Identifies and escalates compliance gaps across quality systems.
Generates and revises standard operating procedures and associated documents as needed.
Identifies compliance risks and escalates the issues to appropriate levels of management for resolution.
Gathers metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is a people driven staffing company. Growing fast - 33% annually!
How? Building trusting relationships with top candidates. Like you! You’ll get one-on-one time focused on your skills, needs, and discovering opportunities in which you’ll thrive. The goal is to place you in the right position for you and your goals.
Where? Top IT and telecommunications companies. You’ll make a difference and grow in Technology, Government Services, Professional Services, or Engineering.
Helping you achieve your goals! It’s the right way and the only way to succeed in staffing.
Experience Required for Your Success
Bachelor's degree required
At least 4 years experience as a Quality Specialist
Experience with QA systems, CAPA, Change Control, and Internal Audits
Pharma or Biotech experience preferred
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.