Specialist, QA Engineering
3 weeks ago
Job Title: Specialist, QA Engineering
Job ID: 24-03763
Location: Warren NJ, 07059
Duration: 12 Months contract on W2
Onsite role, Warren NJ
Work Schedule: Monday - Friday, Business Hours
PURPOSE AND SCOPE OF POSITION:
The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility activities. This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have knowledge and experience with GMP, Quality and compliance.
- Previous experience as a computer system validation / quality assurance for life sciences company regulated by the FDA is preferred.
- Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/facility qualification documentation.
- Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva).
- Drives use of best practices during IT systems design, validation, and use.
- Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
- Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.
- Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
- Consults management for advice on complex issues.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Drive strong collaboration within the site and across the network.
EDUCATION AND EXPERIENCE (As Applicable)
- B.S. degree required.
- 1 - 3 years of experience in the pharmaceutical or related industry.
- Equivalent combination of education and experience acceptable.
WORKING CONDITIONS: (US Only):
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
ADDITIONAL INFORMATION:
- Contingent Workers whose jobs involve the operation of a vehicle or machinery, or physical presence in a laboratory, research, drug development, or manufacturing facility are prohibited from having any amount of alcohol or illicit drugs in their body while in the workplace or performing their job functions.
- Suppliers and the Contingent Worker are responsible for insuring they are fit for all the duties of the job.
-
Specialist, QA Engineering
3 weeks ago
Warren, United States SSi People Full timeTitle: Specialist, QA Engineering Location: Warren, NJ Duration: 12+ Months Pay rate: $40 - 45/hr 1. PURPOSE AND SCOPE OF POSITION: The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility...
-
Specialist, QA Engineering
3 weeks ago
Warren, United States SSi People Full timeTitle: Specialist, QA Engineering Location: Warren, NJ Duration: 12+ Months Pay rate: $40 - 45/hr 1. PURPOSE AND SCOPE OF POSITION: The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility...
-
QA Engineer
2 weeks ago
Warren, United States Axelon Services Corporation Full timeJob Description: Specialist, QA EngineeringOnsite role, Warren NJWork Schedule: Monday - Friday, Business Hours1. PURPOSE AND SCOPE OF POSITION:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and...
-
QA Engineer
2 weeks ago
Warren, United States Axelon Full timeJob Description: Specialist, QA Engineering Onsite role, Warren NJ Work Schedule: Monday - Friday, Business Hours 1. PURPOSE AND SCOPE OF POSITION: The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and...
-
QA Engineer
2 weeks ago
Warren, United States Axelon Services Corporation Full timeJob Description: Specialist, QA Engineering Onsite role, Warren NJ Work Schedule: Monday - Friday, Business Hours 1. PURPOSE AND SCOPE OF POSITION: The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and...
-
QA Specialist
1 month ago
Warren, United States Integrated Resources, Inc (IRI) Full timeJob Description: Quality SpecialistSpecialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with Client policies, standards, procedures, and Global cGMP requirements.This position reports to the Senior Manager of Quality Assurance Operations.Label Printing and Issuance of finished...
-
QA Specialist
1 month ago
Warren, United States Integrated Resources, Inc (IRI) Full timeJob Description: Quality SpecialistSpecialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with Client policies, standards, procedures, and Global cGMP requirements.This position reports to the Senior Manager of Quality Assurance Operations.Label Printing and Issuance of finished...
-
QA Engineer
2 weeks ago
Warren, United States Axelon Services Corporation Full timeAbout Axelon Services Corporation Axelon Services Corporation is a leading provider of specialized services in the life sciences industry. We are committed to delivering high-quality solutions that support our clients' research, development, and manufacturing processes. Job Description: QA Engineer - Cell Therapy Development We are seeking a highly...
-
Structural Engineering Specialist
2 weeks ago
Warren, Maine, United States MartinMartin, Inc. Full timeJob OverviewMartin/Martin, Inc. is on the lookout for a skilled Structural Engineering Specialist to enhance our Investigative Engineering Group. This role offers the chance to engage in structural design for a variety of projects across multiple sectors, including healthcare, commercial, educational, and residential.The ideal candidate will demonstrate...
-
Quality Assurance Engineer
2 weeks ago
Warren, United States Aequor Inc Full timePosition: QA Engineering SpecialistLocation: Warren, NJ 07059Duration: 12 monthsWork Schedule: Monday - Friday, Business HoursPay Rate: $45.45/hr on W21. Purpose And Scope Of Position:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, and review of validation and...
-
Quality Assurance Engineer
3 weeks ago
Warren, United States Aequor Full timePosition: QA Engineering SpecialistLocation: Warren, NJ 07059Duration: 12 monthsWork Schedule: Monday - Friday, Business HoursPay Rate: $45.45/hr on W21. Purpose And Scope Of Position:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, and review of validation and...
-
Quality Assurance Engineer
3 weeks ago
Warren, United States Aequor Full timePosition: QA Engineering SpecialistLocation: Warren, NJ 07059Duration: 12 monthsWork Schedule: Monday - Friday, Business HoursPay Rate: $45.45/hr on W21. Purpose And Scope Of Position:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, and review of validation and...
-
Structural Engineering Specialist
2 weeks ago
Warren, Maine, United States MartinMartin, Inc. Full timeJob OverviewMartin/Martin, Inc. is in search of a skilled Professional Engineer to enhance our Investigative Engineering Group. This role offers the chance to engage in structural design for a variety of projects across different sectors including healthcare, commercial, sports, and residential.The ideal candidate will demonstrate sound judgment in the...
-
Product Design Specialist
4 days ago
Warren, Michigan, United States Waltonen Engineering Full timeJob DescriptionWaltonen Engineering is seeking a skilled Product Design Specialist to join our team.ResponsibilitiesDevelop detailed design layouts for complex units and mechanisms.Conduct design computations as required.Prepare general specifications, such as bills of materials.Collaborate with layout drafters and detailers to achieve a completed...
-
Manufacturing Production Specialist
4 days ago
Warren, United States Connexion Systems & Engineering, Inc. Full timeJob SummaryWe are seeking a skilled Manufacturing Production Specialist to join our team at Connexion Systems & Engineering, Inc.Key Responsibilities:Perform routine setup, operation, and maintenance of manufacturing equipment to ensure optimal production levels.Inspect in-process products to ensure consistent quality and remove defective items.Assist with...
-
Validation Engineer
2 days ago
Warren, United States TSR Consulting Services, Inc. Full timeJob Tittle: Quality Assurance EngineerOnsite role, Warren NJWork Schedule: Monday - Friday, Business HoursJob ID# 80457-1Rate type: W2 only 1. PURPOSE AND SCOPE OF POSITION:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents...
-
Quality Assurance Specialist
3 days ago
Warren, United States Cynet Systems Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Cynet Systems.Job Summary:The Quality Assurance Specialist will be responsible for ensuring the quality and compliance of our products and services. This includes:Validating and qualifying equipment and facilities to ensure they meet regulatory...
-
Quality Engineer
2 days ago
Warren, United States SPECTRAFORCE Full timeSpecialist, QA EngineeringOnsite role, Warren NJ, 07059Work Schedule: Monday - Friday, Business HoursDuration: 12 Months1. PURPOSE AND SCOPE OF POSITION:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment...
-
Quality Assurance Engineer- W2 only
3 weeks ago
Warren, United States TSR Consulting Services, Inc. Full timeJob Tittle: Quality Assurance EngineerOnsite role, Warren NJWork Schedule: Monday - Friday, Business HoursJob ID# 80307-1Rate type: W2 only 1. PURPOSE AND SCOPE OF POSITION:The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents...
-
Quality Assurance Engineer/ Validation Analyst
2 weeks ago
Warren, United States TSR Consulting Full timeJob Tittle: Quality Assurance Engineer Onsite role, Warren NJ Work Schedule: Monday - Friday, Business Hours Job ID# 80307-1 Rate type: W2 only 1. PURPOSE AND SCOPE OF POSITION: The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification...