Senior Validation Consultant
4 weeks ago
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
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Senior Validation Consultant
1 month ago
Rockville, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: 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...
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Associate Director of Validation Consultant
3 weeks ago
Rockville, United States The Verity Collective Full timeJob 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 equipment qualification lifecycle. 2. Gap Assessment of Validation Plan for both...
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Senior Consultant | Salesforce
1 week ago
Rockville, United States fusionSpan Full timeJob DescriptionJob DescriptionfusionSpan is a dynamic, fast-paced organization. We are a team of highly committed individuals who are inspired by the role technology plays in society. Our lead business analysts are capable of leading requirements gathering for enterprise, multi-phase, multi-platform projects. This position is 100% remote. A...
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Validation Engineer III
2 days ago
Rockville, United States AstraZeneca Full timeJob Title: Validation Engineer III Introduction to Role: Join us as a Validation Engineer III, where you will provide technical and system support to Development Quality Biologics, BPD and Facilities. This role involves reviewing and approving validation protocols and reports, authoring technical documentation related to validation, qualification and risk...
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Associate Director, Validation
1 month ago
Rockville, United States AstraZeneca Full time**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 Risk assessments, validation project plans, User Acceptance tests, and reports. -...
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Rockville, MD, United States Rogers & Peters, LLC Full timeJob Description Job Description Join Our Team: CPA | Senior Tax Manager | Senior Audit Manager Opportunities at Rogers & Peters, LLC About Rogers & Peters, LLC: Established in 1998, Rogers & Peters, LLC is a reputable CPA firm based in the heart of our local community. We provide a wide range of accounting, auditing, and financial services to a diverse...
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Senior Facilities Consultant
1 month ago
Rockville, United States Quality Agents Full timeQuality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Minimum Requirements: BS in a technical discipline (Engineering, chemistry, microbiology, biology) 7+ years of experience in at least one of the following areas: equipment/utility qualifications, process validation,...
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Senior Facilities Consultant
9 hours ago
Rockville, United States Quality Agents Full timeQuality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Minimum Requirements: BS in a technical discipline (Engineering, chemistry, microbiology, biology) 7+ years of experience in at least one of the following areas: equipment/utility qualifications, process validation,...
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Senior Mechanical Engineer
1 week ago
Rockville, United States Futures Consulting Full timeJob Description We are driven by inspiring the right people to be part of our future-focused business objectives. Our devotion to teamwork has allowed us to build communities and expand our skylines. Our firm is a world-class multi-disciplinary engineering consulting firm, is seeking a Senior Mechanical Engineer for our Rockville MD office. We work closely...
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Senior Financial Analyst
4 days ago
Baltimore, MD, United States Erickson Senior Living Full timeLocation: Erickson Senior Living Erickson Senior Living, headquartered in Baltimore, Maryland is a national provider of senior living and health care with campuses in 11 states—and growing. Erickson Senior Living develops and manages senior living communities and health services across the country. We achieve industry–leading results in customer...
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Senior Mechanical Engineer
1 week ago
Rockville, United States Futures Consulting Full timeJob DescriptionWe are driven by inspiring the right people to be part of our future-focused business objectives. Our devotion to teamwork has allowed us to build communities and expand our skylines. Our firm is a world-class multi-disciplinary engineering consulting firm, is seeking a Senior Mechanical Engineer for our Rockville MD office. We work closely...
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Data Reporting and Analytics Consultant III
2 weeks ago
Rockville, United States Kaiser Permanente Full timeJob Summary: This individual contributor is primarily responsible for supporting data-informed decisions, gathering data and information on targeted variables in an established systematic fashion, and preparing data for analytic efforts. This position supports the execution of creative data analytic approaches leading to actionable outcomes, develops,...
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Senior Estimator
1 week ago
Rockville, United States Source2 Full timePosition: Senior Estimator (Stormwater/Utilities)Industry: Operational ServicesLocation: RemoteHiring Immediately!Are you highly motivated, hard-working, and seeking to join a growth-focused environmental consulting & engineering firm? Are you looking for a company that will invest in your development and grow your professional skills? If so, consider a...
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Senior Estimator
13 hours ago
Rockville, United States Source2 Full timePosition: Senior Estimator (Stormwater/Utilities)Industry: Operational ServicesLocation: RemoteHiring Immediately!Are you highly motivated, hard-working, and seeking to join a growth-focused environmental consulting & engineering firm? Are you looking for a company that will invest in your development and grow your professional skills? If so, consider a...
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Senior Laboratory Scientist
4 days ago
Rockville, United States Psomagen Inc Full timeJob DescriptionJob DescriptionSenior Laboratory ScientistRockville, MD, USRequisition ID: 1135ApplyJob Title: Senior Laboratory ScientistOverview:Psomagen is seeking a highly skilled and motivated Lead Laboratory Scientist with a strong background in genomic sequencing to join our dynamic team. The successful candidate will be responsible for processing...
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Senior Laboratory Scientist
1 week ago
Rockville, United States Psomagen Inc Full timeJob DescriptionJob DescriptionSenior Laboratory ScientistRockville, MD, USRequisition ID: 1135ApplyJob Title: Senior Laboratory ScientistOverview:Psomagen is seeking a highly skilled and motivated Lead Laboratory Scientist with a strong background in genomic sequencing to join our dynamic team. The successful candidate will be responsible for processing...
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Senior Laboratory Scientist
16 hours ago
Rockville, United States Psomagen Inc Full timeJob DescriptionJob DescriptionSenior Laboratory ScientistRockville, MD, USRequisition ID: 1135ApplyJob Title: Senior Laboratory ScientistOverview:Psomagen is seeking a highly skilled and motivated Lead Laboratory Scientist with a strong background in genomic sequencing to join our dynamic team. The successful candidate will be responsible for processing...
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Audit Senior/Manager
6 days ago
Rockville, MD, United States Saggar & Rosenberg, P.C. Full timeSaggar & Rosenberg is a boutique Certified Public Accounting and Management Consulting Firm founded in 1999. Headquartered in Rockville, Maryland, Saggar & Rosenberg provides a vast array of specialized tax, accounting and business advisory services to our clients not only in the Washington, DC metropolitan area, but also nationally and internationally....
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Audit Senior Manager
6 days ago
Rockville, MD, United States Saggar & Rosenberg, P.C. Full timeSaggar & Rosenberg is a boutique Certified Public Accounting and Management Consulting Firm founded in 1999. Headquartered in Rockville, Maryland, Saggar & Rosenberg provides a vast array of specialized tax, accounting and business advisory services to our clients not only in the Washington, DC metropolitan area, but also nationally and internationally....
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Bethesda, MD, United States Elevance Health Full timeElevance Health Provider Contract/Cost of Care Consultant Senior Nashville , Tennessee Apply Now Provider Contract/Cost of Care Consultant Senior-Analytics Location: This position will work a hybrid model (remote and office). Must live within 50 miles/1 hour commute of one of our Elevance Health locations. The Extended Value Analytics and Optimization...