What are the responsibilities and job description for the Quality Analyst I position at AMISEQ?
Job Description:
This position is primarily responsible to support Projects under Quality Organization. The projects are related but not limited to the following: Batch Record Review Process Simplification, Quality KPI-RFT Metrics Acquisition and Evaluation/Reporting, Standardization of the Deviations Tracking System, Doc Control Off load. The main responsibility of this position is to identify areas for simplification while looking for efficiencies on Quality processes. The temporary resource will apply project management skills, DMAIC tools and operational excellence tools such as 5S, Value Stream mapping, and evaluation of wastes and suggest new potential process maps based on inputs of the areas. Also, coordinate meetings, conduct data gathering and evaluate results.
Duties:
- Responsible to collect data through observation of tasks, duties
- Develop current state of process map of the area identified.
- Coordinate meetings for the data/process evaluation
- Identify areas of opportunities and discuss with the area manager and QLT.
Develop proposal new state for the process evaluated.
- Develop plan, establish the support required for procedures updates and training required
- Identify metrics to be used to monitor
- Execute plan
Position Requirements:
- Any equivalent combination of education, training and or experience that fulfils the requirements of the position will be considered.
Must Have:
- Bachelor's degree on Engineering, Biology, Chemistry or equivalent. from an accredited college or university, with a minimum of 1-3 years relevant progressive cGMP compliance experience within the manufacturing/pharmaceutical industry.
- Experience with project management, process excellence, pharmaceutical environment.
- Quality experience
- GMP experience
- Manufacturing experience
- Experience Microsoft PowerPoint, Excel
Skills/Knowledge/Abilities:
- Establishing and maintaining cooperative working relationships with others.
- Reading, understanding, interpreting and complying with current Company policies and procedures including safety rules and regulations.
- Communicating clearly and concisely, both orally and in writing.
- Operating personal computer and database software.
- Handling multiple projects, duties and assignments.
- Quality Assurance methods and procedures.
- Related business, scientific and personal computer hardware and software applications in area of assignment.
- Computer literate and experience with Microsoft Word, Excel, PowerPoint, Visio tools
Visual Acuity:
- Perform activities such as computer work, preparing and analysing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
