Quality Analyst at Stefanini Group

Stefanini Group is hiring!

Stefanini is looking for Quality Analyst in Davie, FL

For quick Apply, please reach out to Kamal Rawat - call: 2487286412 / email: kamal.rawat@stefanini.com

Work Hours: (M-F 8:30 AM – 5:30 PM) (40 hours) 

Work Location: Davie, FL 

Shift: 1^st Shift
 

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 gatherings, and evaluate results.

Essential Areas of Responsibility:

• Responsible for collecting 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

Core Essential Skill sets candidates must have to be considered for the role:

• Min Bachelor Degree on Engineering, Biology, Chemistry or equivalent
• Experience with project management, process excellence
• Pharmaceutical environment
• Quality experience
• GMP experience
• Manufacturing experience
• Experience Microsoft PowerPoint, Excel
   

Qualifications:

• Bachelor Degree in 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

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.

Problem Solving:

• Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
• Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
• Normally receives general instruction on routine work and detailed instruction on new assignments.
• May be asked to recommend methods and procedures for problem resolution.
• Computer literate and experience with Microsoft Word, Excel, PowerPoint, Visio tools
• Details oriented with ability to identify areas for improvement
• Ability to perform capacity analysis
• Ability to build and maintain collaborative relationship between teams and departments
• Self-directed with ability to organize and prioritize work
• Ability to communicate effectively with excellent written and oral communication skills
• Ability to interact positively and collaborate with co-workers management

Physical Requirements:

Frequent:

• Standing for extended periods of time at workstation or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:

Perform activities such as computer work, preparing and analyzing 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.

Working Environment:

• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations. May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e., safety glasses, respirator, hearing protection, gloves, etc.).

 Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process, including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.

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