Commissioning/Qualification Specialist - LanceSoft Inc
Summit, NJ 07901
About the Job
Job Title: Validation Qualification Specialist
Location: Summit NJ 07901
Duration: 12 Months
Minimum 50% onsite required
work schedule- Normal Business hours
Essential Functions:
Required Competencies-Knowledge, Skills, and Abilities:
Competencies:
Education & Experience:
Working Conditions:
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time
Location: Summit NJ 07901
Duration: 12 Months
Minimum 50% onsite required
work schedule- Normal Business hours
Essential Functions:
- Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
- Support Lifecycle Document Management System
- Develops protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment qualifications and validation protocols
- Supervises vendors for qualification functions.
- Develops written procedures for calibration and preventive maintenance of equipment
- Supports calibration, equipment qualification and validation activities.
- Configures and documents the configuration of computerized systems
- Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Manages projects of varying scope and complexity.
- Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Client standards.
- Provides excellent customer service and support.
- Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Required Competencies-Knowledge, Skills, and Abilities:
- Strong critical thinking skills.
- Ability to learn and function in a fast paced environment
- Experience executing qualification documents
- Ability to interact effectively with laboratory, QA, and Facilities groups
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
- Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
- Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.
Competencies:
- Technical / Professional Knowledge
- Problem Solving / Troubleshooting
- Action Oriented
- Attention to Detail
- Multi-tasking
- Building Relationships
Education & Experience:
- BS degree in Engineering / Computer Science or equivalent
Working Conditions:
- Environment may include working in office or in a laboratory / manufacturing area.
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- Ability to work safely when working alone, or working with others.
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)
- Four options of Medical Insurance
- Dental and Vision Insurance
- 401k Contributions
- Critical Illness Insurance
- Voluntary Permanent Life Insurance
- Accident Insurance
- Other Employee Perks
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time
Source : LanceSoft Inc
