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Associate Director of Validation Consultant
5 days ago
The Verity Collective Rockville, United StatesJob Overview: · We are seeking a highly skilled Associate Director of Validation (10+ years experience) to join our team as a consultant for a 6-9 month on-site Contract in Rockville, MD. · 1. Review and enhance Validation Master Plan to include comprehensive facility and equipme ...
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Senior Validation Consultant
1 day ago
Katalyst HealthCares & Life Sciences Rockville, United StatesResponsibilities: Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements. · Prepare training materials and perform training and coaching for all team members. · Perform validation of products ...
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Security Consultant Technical Validator
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IBM Alexandria, United StatesIntroduction · At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are ...
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Associate Director, Validation
2 hours ago
AstraZeneca Rockville, United States**What you'll do**: · - Own and maintain a robust qualification and quality program to support and maintain a qualified and compliant state facility, including processes, laboratories, and utility equipment. · - Support Computerized System Validation (CSV) documents including Ris ...
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Car Sales Consultant Darcars of Rockville
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DARCARS Automotive Group Rockville, United States**DARCARS Automotive Group **is now hiring **Car **Sales Consultants **to join our team · **No Experience Needed, We Provide Paid Training** · **Potential Earning up to 6 Figures First Year** · As a **Car **Sales Consultant** you are directly responsible for selling new and used ...
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Environmental Scientist
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Associate Scientist
4 days ago
Actalent Rockville, United States Full timeDescription: · Responsibilities: · Maintain aseptic cell cultures, ensuring their viability and health. · Monitor cell lines, troubleshoot issues, and optimize growth conditions. · Perform immunocytochemistry assays to detect specific proteins or markers within cells. · Analyze ...
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Service Advisor Darcars of Rockville
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Quality Assurance Analyst
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Digital Strategy LLC Rockville, United StatesDigital Strategy LLC is seeking a **Quality Assurance Analyst **to help drive impactful insights through the delivery of pivotal data analytics products tailored for federal clients. Our data analytics solutions make a meaningful impact on government staffing, engagement, perform ...
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Project Control Analyst
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WESTAT Rockville, United StatesWestat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in ...
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Associate Scientist
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Actalent Rockville, United States Full timeDescription: · Bioanalytical contractor that will be working for 2 groups under the R&D umbrella. The scope of the role will be split between Cell Culture work and the Bioanalytical side of things. Here is some high level background on the position:1. Describe in just a few sente ...
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Nurse Practitioner
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Ikon Health Montgomery County, MD, United States**About Ikon Health** · Ikon Health is a premier leader in providing primary care house-calls to the homebound throughout Montgomery, Howard and Prince George's Counties, MD. Our goal is to provide high quality medical care to the homebound geriatric community, ensuring they have ...
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Supervisory Health Scientist Administrator
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US National Institutes of Health Montgomery County, MD, United States**Duties**: · As a **Supervisory Health Scientist Administrator (Program Officer)**, you will perform the following tasks: · - Manage and coordinate all functional requirements of the organization in an Extramural Division. · - Supervise Health Scientist Administrators, other sci ...
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Us Posting Template
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The EMMES Corporation Rockville, United StatesOverview: · **Job Posting Title** · **US Remote/Rockville/Frederick** · Emmes Group: Building a better future for us all. · Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was ...
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Purchasing Agent
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US National Institutes of Health Montgomery County, MD, United States**Duties**: · - Contact vendors to advise them of ordering requirements and technical specifications and to discuss price quotations and other matters related to the purchase. · - Prepare and evaluate vendor list and unit prices to secure a fair and reasonable price for volume bu ...
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Clinical Trials Administrator Analyst I
4 days ago
The EMMES Corporation Rockville, United StatesOverview: · **Clinical Trials Administrator Analyst I** · **US Remote** · Emmes Group: Building a better future for us all. · Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group w ...
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Montgomery County Government Gaithersburg, United States**This position is open only to**: · **(1) Current Montgomery County Government employees;** · **(2) Montgomery County employees who were affected by reduction-in-force and currently have RIF priority rights;** · **(3) Active Montgomery County local fire and rescue department vol ...
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Phlebotomist Gaithersburg
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Actalent Gaithersburg, United States Full timeDescription: · Summary: The main function of a phlebotomist is to assist in performing various assigned duties trouble shooting training and making work flow recommendations. · Position Responsibilities: Experience doing blood draws labeling specimens centrifuging specimens reco ...
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Global Technical Operations, Director
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AstraZeneca Gaithersburg, United States**Introduction to role**: · Join us in a cross-functional leadership role within the Global Technical Operations (GTO) team, focusing on the strategic planning and coordination of technical leadership for our radioconjugate platforms. This role is a unique opportunity to make an ...
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Automotive Body Shop Estimator
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Sheehy Ford Gaithersburg Gaithersburg, United States**Sheehy Auto Stores is one of the country's Top 30 Private Dealer groups representing some of the industry's best brands with over 25 locations. Sheehy Auto Stores prides itself on finding the best team members, both experienced and new to the industry, who have that desire to a ...
Senior Validation Consultant - Rockville, MD, United States - Katalyst Healthcares & Life Sciences
Description
Responsibilities:
Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements.
Prepare training materials and perform training and coaching for all team members.Perform validation of products and services and qualification of software/hardware (Clinical SaaS software (customer facing), SDLC tools and other operational enablement software that are internal) Manage a continuous improvement backlog for all processes enforced by the SDLC and CSV validation procedures.
Ensure training gaps, process gaps, audit findings and quality incidents have corrective and preventive actions in place.Liaison with business, technical and other compliance stakeholders to ensure the SDLC procedures and associated templates work as intended to enforce compliance at all levels.
Participate in remediating audit findings and quality incidents.Requirements:
Well versed with GxP validation protocols aligned to US FDA CFRs particularly 21 CFR Part 11 for electronic records and electronic signatures and EU guidelines including Annex 11.
Hands on experience validating cloud applications including portals, websites, and mobile applications. Experience validating systems that are AI/Client products in itself or use AI/Client components. Strong focus on risk assessment and validation of parameters impacting patient safety, product quality and data integrity. Ability to perform regulatory interpretation as and when required and provide data and clarifications.Be able to develop metrics to assess validation throughput, record and follow up on non-conformances as well as CAPA from product requirement initiation to launch.
Experience ensuring audit readiness and leading audits Experience in audit readiness for FedRAMP certification
