What are the responsibilities and job description for the Quality manufacturing Analyst position at Select Source International?
Core Essential Skill sets candidates must have to be considered for the role:
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.
Essential Areas Of Responsibility
Any equivalent combination of education, training and or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience
Frequent
Physical Requirements:
Standing for extended periods of time at work station 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.).
Screenings
Basic Bkg
11 Panel Drug with Fentanyl
Medical Screenings
- 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
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.
Essential Areas Of Responsibility
- 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
Any equivalent combination of education, training and or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience
- Bachelor 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
- 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, 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
Frequent
Physical Requirements:
Standing for extended periods of time at work station 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.).
Screenings
Basic Bkg
11 Panel Drug with Fentanyl
Medical Screenings
- Vision Screenings - Far, Near, Depth, and Peripheral
- Vital Signs
- Whisper Test
- Lifting Assessment: max 25 pounds
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