Quality Analyst Job Description Template
Our company is looking for a Quality Analyst to join our team.
Responsibilities:
- Evaluate progress reports, concerns, obstacles or challenges to the appropriate leadership team;
- Manage risk-related issues that arise and implement controls to avoid recurrence;
- Implement and maintain processes to achieve efficient workflow;
- Perform additional duties and responsibilities as required by leadership;
- Coordinate all aspects of the quality control improvement from start to finish;
- Contribute ideas on systems and process methods to improve deliverables;
- Assist with training, implementation, updating, and creation of procedures;
- Monitor, evaluate, trend, approve and maintain multiple aspects of NCIRs and related documentation;
- Work cross-departmentally to identify and resolve quality concerns;
- Coordinate, liaise and participate with internal teams to provide guidance on regulatory and/or quality system compliance;
- Proactively identify potential quality control issues and work with internal resources on solutions;
- Analyze business requirements;
- Identify incongruencies with test plans;
- Present ideas in business-friendly and technical-friendly language;
- Participate in reviews, meetings and stage gate reviews.
Requirements:
- Bachelor’s degree;
- Hands-on manufacturing experience;
- Bachelor’s degree in logistics, Engineering and supply chain or related discipline;
- Knowledge of Quality Systems including QSR/GMP’s, relevant ISO Standards;
- Demonstrated ability to successfully lead and strengthen teams and projects;
- Minimum of three (3) years of experience in a progressive role inventory control/warehouse environment;
- Ability to perform all job duties in compliance with Person First standards, HIPAA guidelines, and company confidentiality policies;
- Advanced computer skills and proficiency in MS Word, Excel, Outlook, PowerPoint, MS Project, and Visio – preferred;
- Familiarity with PowerBI, MiniTab, Tableau;
- Experience of CMS, CLIA and/or FDA, GCP/GLP, regulations and guidance – required;
- Previous experience supporting audit activities;
- Adaptability to learn and work with new computer applications;
- Familiarity with medical devices;
- Bachelor’s Degree in Clinical Laboratory Science or related science such as Chemistry, Microbiology – Highly preferred;
- Ability to successfully execute many complex tasks simultaneously.