Quality Assurance Specialist
13 hours ago
Job Opportunity: Consultant – QA IT Quality Specialist
Employment Type: Contract
Location: White Plains, NY (Onsite)
Duration: 6 months with potential extensions
Position Overview:
We are seeking a Consultant – QA IT Quality Specialist to provide expert guidance in IT Quality and Data Integrity programs. The role involves ensuring compliance with GxP regulations and verifying the proper operation of GxP computerized systems post-validation. This position requires collaboration with various teams to establish and maintain compliant policies and procedures, as well as interaction across all organizational levels to fulfill Quality Assurance responsibilities efficiently.
Key Responsibilities:
- Partner with Corporate IT and IOPS IT teams to ensure IT processes align with the Client's Quality System requirements.
- Apply Quality Risk Management (QRM) principles to both formal and informal risk assessments.
- Provide expertise in quality system records, including change controls, CAPAs, risk assessments, data integrity, deviations, audits, SOPs, work instructions, and policies.
- Support IT vendor audits and Quality Assurance Agreement (QAA) development, including the Approved Supplier List (ASL) process.
- Collaborate with cross-functional teams to gather information and guide quality management initiatives.
- Ensure new systems, processes, and procedures comply with regulatory requirements and validation guidelines for IT and software.
- Assist in resolving software application and data integrity concerns during inspection management.
Required Experience and Qualifications:
- Minimum of 10+ years in IT, Computer Science, Engineering, or Chemistry within an FDA-regulated manufacturing environment.
- Comprehensive experience of IT CSV (Computer System Validation) and QA IT responsibilities supporting GxP compliance.
- Experience applying a risk-based approach to validation/qualification in FDA-regulated environments.
- Strong understanding of FDA CFRs, Eudralex, and other industry regulations related to IT, laboratory systems, automation, and manufacturing.
- Expertise in Data Integrity, SDLC validation methodology, and software quality requirements.
- Proficient in root cause analysis and risk management techniques.
- Hands-on experience with quality management systems such as change control, incident management, and deviation handling.
- Demonstrated project management skills, with experience leading cross-functional validation efforts (e.g., laboratory equipment, facilities, utilities, manufacturing equipment, and information systems) is a Must
- Strong technical writing, analytical, and communication skills.
- Proven ability to drive process improvements and deliver enhanced performance.
If you are an experienced professional passionate about IT Quality and eager to make a meaningful impact in a dynamic environment, we encourage you to apply.
-
Quality Assurance Specialist
59 minutes ago
White Plains, United States MasterCompliance LLC Full timeJob Opportunity: Consultant QA IT Quality Specialist Employment Type: Contract Location: White Plains, NY (Onsite) Duration: 6 months with potential extensions Position Overview: We are seeking a Consultant QA IT Quality Specialist to provide expert guidance in IT Quality and Data Integrity programs. The role involves ensuring compliance with GxP...
-
Quality Assurance Specialist
19 hours ago
Plains, United States Procure Personnel Full time $19 - $20We are looking to hire a Quality Assurance Specialist for the Pittston Area. Responsibilities: Perform Pre-Shipment Inspection checks for all shipments per internal checklist.Train factory personnel to Perform Pre-Shipment Inspection checks for all shipments per internal checklist.Perform regular factory audits to monitor and measure conformance of the...
-
North Plains, Oregon, United States ALIGN PRECISION - NORTH PLAINS, LLC Full timeJob Description**Alignment of Quality and Excellence**We are seeking a highly skilled and experienced Calypso Quality Assurance Specialist to join our team at ALIGN PRECISION - NORTH PLAINS, LLC. This individual will play a critical role in ensuring the quality and precision of our products.Key Responsibilities:Conduct thorough inspections of raw materials,...
-
North Plains, Oregon, United States ALIGN PRECISION - NORTH PLAINS, LLC Full timeJob Title: Calypso Quality Assurance SpecialistALIGN PRECISION - NORTH PLAINS, LLC seeks a meticulous and detail-oriented Calypso Quality Assurance Specialist to drive quality excellence throughout our organization. This key position involves implementing and maintaining robust quality control measures to guarantee the highest level of product...
-
West Plains, Missouri, United States EIHAB Full timeAbout the Job DescriptionThe Quality Assurance Specialist is responsible for ensuring that services are rendered in accordance with all safety regulations, federal and state regulations, and agency policies. This includes monitoring and overseeing program compliance, identifying areas for improvement, and developing strategies to address these gaps.Required...
-
Contract Quality Assurance Professional
3 days ago
White Plains, New York, United States Madison Approach Full timeAbout the RoleThis Contract Specialist position is ideal for individuals who enjoy working in a dynamic environment and possess excellent analytical, communication, and problem-solving skills.Responsibilities and ExpectationsDevelop Contracting Mechanisms and Strategies: Create efficient processes and procedures to reduce cycle time.Monitor Contract...
-
Quality Assurance Specialist
3 days ago
White City, Oregon, United States Emerald Technologies Full timeJob OverviewEmerald Technologies is a leading provider of electronic manufacturing services (EMS) to original equipment manufacturers (OEMs). We specialize in high-reliability electronic assemblies for various industries, including Aerospace/Defense, Life Sciences, Renewable Energy, Industrial Controls, Power & Infrastructure, Semiconductor, and...
-
Senior HIM Support Specialist
6 days ago
White Plains, New York, United States White Plains Hospital Full timeAbout the Role:As a Sr. HIM Specialist at White Plains Hospital, you will be responsible for ensuring the highest quality of patient health information and providing exceptional customer service. You will work closely with the Director of Health Information Management to develop and implement processes that improve workflow efficiency and ensure compliance...
-
Diagnostic Imaging Specialist
4 days ago
White Plains, New York, United States i4 Search Group Healthcare Full timeJob DescriptionWe are seeking a highly skilled Diagnostic Imaging Specialist to join our team. As an integral member of our radiology department, you will play a vital role in providing high-quality ultrasound examinations to our patients.Your key responsibilities will include:Performing routine and specialized diagnostic ultrasounds using advanced imaging...
-
Sr. HIM Specialist
16 hours ago
White Plains, United States White Plains Hospital Full timePosition Summary: Under the direction of the Director of Health Information Management, the SR. HIM Support Specialist & Audit Liaison, is the knowledge expert responsible for the processing of all release of medical records information requests in a timely and efficient manner ensuring accuracy and providing customers with the highest quality product and...
-
Diagnostic Imaging Specialist
6 days ago
White Plains, New York, United States Stability Direct Full timeStability Direct is a leading provider of permanent placement services in the healthcare industry.We are seeking an experienced Diagnostic Imaging Specialist to join our team.The successful candidate will be responsible for performing diagnostic and special procedure medical radiographic images utilizing CAT scan equipment.Key responsibilities...
-
Morris Plains, New Jersey, United States Veracity Full time**Our Company Culture:** At Veracity, we foster a collaborative and dynamic work environment that encourages innovation and creativity. Our team members are experts in their fields, and we're committed to providing them with the resources and support they need to excel.Job Summary: We're seeking a skilled Mainframe QA Analyst to join our team. In this role,...
-
Medical Imaging Specialist
6 days ago
White Plains, New York, United States Stability Direct Full timeAt Stability Direct, we are seeking a highly skilled Medical Imaging Specialist to join our Radiology Department. As a key member of our team, you will be responsible for performing routine and special procedure imaging using CT equipment.About the JobWe are looking for an individual who is passionate about delivering high-quality patient care and has...
-
Development Quality Engineer
8 hours ago
White, United States Q-Cells Full timeDescription SUMMARY The Development Quality Engineer will play a critical role in ensuring quality assurance and management throughout the product development lifecycle, from initial planning to final production. This position collaborates with development teams to establish quality standards, proactively prevent issues, and secure the quality of the final...
-
Senior A/R Specialist
11 hours ago
White Plains, United States White Plains Hospital Full timeAt White Plains Hospital, you have an opportunity to work side-by-side with some of the most talented people in the world. We have been widely recognized for our exceptional culture, world-class physicians, Magnet-designated nurses and passionate employees who make a real difference in our community. With tremendous growth opportunities, great benefits, and...
-
Travel Nurse CVICU Specialist
3 days ago
White Plains, New York, United States Assured Nursing Full timeAssured Nursing is currently seeking a travel nurse for a contract position in New York.About the RoleSpecialty: Cardiovascular Intensive Care Unit (CVICU)Discipline: Registered Nurse (RN)The ideal candidate will possess current state licensure as a RN and have at least 2 years of recent experience as a CVICU RN.We offer a tax-free stipend amount to be...
-
Cold Plate Quality Assurance
3 days ago
White Hall, Arkansas, United States Wieland Full timeJoin Our TeamWe are looking for a highly motivated and experienced Quality Technician to join our team at Wieland.In this role, you will be responsible for ensuring the highest quality standards in our cold plate large volume and aerospace manufacturing environment.You will perform quality inspections, manage calibration processes, and collaborate with...
-
Medical Laboratory Specialist
6 days ago
White Plains, New York, United States White Plains Hospital Full timeJob OverviewWe are seeking a skilled Medical Laboratory Specialist to join our team at White Plains Hospital. As a key member of our laboratory team, you will be responsible for performing clinical microbiology tests using manual and automated techniques.Key Responsibilities:Performing clinical microbiology tests using manual and automated...
-
Estimating Specialist
1 day ago
White Plains, New York, United States Lighthouse Professional Services Full timeEstimating Role OverviewLighthouse Professional Services seeks a skilled Estimating Specialist to support our capital projects team. As an Estimating Specialist, you will be responsible for developing detailed estimates for various projects, ensuring that all necessary information is included and that the estimates meet client expectations.Main...
-
Mental Health Case Manager Specialist
6 days ago
White Plains, New York, United States Sun River Health Full timeKey ResponsibilitiesPatient Care:Plan, develop, and oversee psychosocial services and support groups for clients and caregivers.Manage admissions and discharges in alignment with client needs, conduct psychosocial assessments, and document case notes.Provide psychotherapy and lead or co-lead psychosocial support groups for family members, significant others,...