Quality Assurance Specialist Position Available In Florence, South Carolina

Job Title:

Quality Assurance Specialist Location:

Florence, SC 29506

Duration:

12 months

Shift:

M-F Flex around 6-9am start (8 hours per day). OT as needed.

Pay rate:

$28/hr on W2

Position Summary:

Work directly with customers and suppliers to quickly address quality related issues. Responsible for the day-to-day execution of core quality processes under the supervision of Director, Quality Assurance with mentoring from more senior QA Specialists (Skill levels II and III).

Key Responsibilities:

Participate in all aspects of the QA job function, e.g. processing of Complaints, Quarantine, Recovery, Customer Recovery and Advisories (QRRs), change notifications, customer surveys, quality certificates, internal audits, Sales Logix tickets, generation of supplier and team metrics, etc. Process the download and distribution of Complaints daily. Identify those Complaints requiring escalation. Work with customer service to fully document the customer’s allegation and facilitate the return of product to be evaluated. Coordinate investigations with suppliers, and communicate root cause and corrective actions to customers. Coordinate investigation of quality issues with customers and suppliers. Review, approve and communicate root cause and corrective action to stakeholders. Facilitate the quarantine, recovery and disposition of products including those that may be sensitive in nature for regulatory or legal reasons. Create and revise QA procedures and work instructions. Participate in internal audits of the Quality Management System. Participate in continuous improvement of core processes, using Practical Process Improvement (PPI).

Minimum Requirements/Qualifications:

Bachelor’s Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. Minimum two years’ experience working in an ISO (13485 preferred) and/or FDA current Good Manufacturing Practices (cGMP) environment. Strong computer and analytical skills, including: Data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Data Warehouse tools. Experienced in a continuous improvement methodology and related analytical tools, e.g. Six Sigma, PPI, Lean, Minitab, Corrective and Preventive Action (CAPA), run charts, flow charting, Pareto charts, pivot tables etc. Experienced internal or external auditor, lead auditor experience preferred. Experience working with a quality information management system, Master Control preferred.