Remedy Professional Placement is seeking a Quality Systems Specialist for a local Biotech manufacturing company in Norfolk, Virginia.
The Quality Systems Specialist will be a highly motivated individual, self-started with an A+ attitude and proven ability to follow through who will be involved in managing agile/lean operations. The position will manage a number of tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all GXP quality systems.
Requires a good working knowledge, comprehension, and experience with quality systems, measuring techniques and equipment in a regulated (GMP) environment. Strong verbal, written and technical skills required. Able to work with minimal supervision, demonstrate initiative and self-direction. Ability to collaborate and assist with solving practical problems. Strong interpersonal skills including teamwork, listening and giving feedback are required.
- Provide leadership to and manage the daily activities of the QA Systems and Compliance.
- Demonstrate leadership by ensuring the continuous improvement of the Quality Management Systems,
- Manage the Internal and External Audit programs to ensure Suppliers are in compliance with applicable regulations.
- Formulate and implement the Business’ long-range quality and compliance policy.
- Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction
- Works in partnership with Manufacturing, Engineering, Maintenance and Quality in designing and enhancing Quality Management Systems to facilitate overall regulatory compliance and conformity to ISO 9001 requirements.
- Develops and maintains internal audit plans
- Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training
- Document Control, Management Controls, Internal Audits.
- Manage multiple Global Quality Systems functions including but not limited to: Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training; Document Control, Management Controls including Management review and Quality Planning; Internal Audit Programs
- Take initiative to liaise with external QMS consultants and regulatory counsel to confirm sufficiency of quality systems and documentation
- Experience in managing external Audits, Customer, ISO and/or FDA Inspections
- Proven ability to collaborate with all levels/functions in executing quality objectives
- Technical and business writing and presentation experience and delivery
- Bachelor’s degree or higher in relevant field
- Track record of meeting deadlines and goals
- LEAN manufacturing experience preferred
- Strong problem solving and analytical skills
- Multi-tasking and prioritizing responsibilities