Quality Systems Specialist Job Description Template
Our company is looking for a Quality Systems Specialist to join our team.
- Oversight of Policy/SOP/SOI/WI compliance;
- Assist Quality Manager in developing annual quality plan and quality summit;
- Host audits and respond to audit findings;
- Conduct and manage training compliance to include GMP;
- Development of procedures and controls in support of the Quality Management System;
- Identify and implement potential improvement projects, as appropriate;
- Responsible for compiling and reporting monthly metrics related to quality systems;
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations;
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance;
- Co-ordinates legal requests in support of government investigations or litigations;
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally;
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Bachelor’s degree, preferably in Business or Science related field;
- Proficient with Microsoft Office (Excel, Work, Outlook, PowerPoint);
- Experience with customer and regulatory audits/inspections;
- Minimum of 5 years of experience in a QA/QC position in a regulated industry;
- Demonstrated ability to lead and train other associates;
- Experience with implementation of quality systems;
- 2 – 3 years’ dietary supplement, food or pharmaceutical experience;
- Working knowledge of 21 CFR 111 and 21 CFR 117;
- Excellent communication skills, both written and verbal;
- Proven ability to independently prioritize tasks.