Jobbörse
Finde Jobs in deiner Nähe – ob vor Ort, hybrid oder remote.- Ähnliche Jobs zu: QA Validation Specialist
QA Validation Specialist
Pinnaql Inc.SanfordQA Validation Specialist Description The QA Validation Specialist serves as a dedicated member of the QA Validation organization, supporting equipment qualification and lifecycle management activities
Remote QA Release & Validation Specialist
RadiometerFargoRadiometer in Fargo, ND is seeking a Quality Assurance professional to ensure compliance with quality standards. Responsibilities include reviewing production records, serving as the QA expert, and va
Pharma IT QA & CSV Validation Specialist
CiplaHauppaugeCipla is seeking a QA Associate (IT) in Hauppauge, NY, to ensure the compliance and performance of IT systems in a pharmaceutical manufacturing environment. You will validate IT systems, focusing on a
CSV & QA Validation Specialist - Digitalization & Compliance
Bentley InnoMed GmbHNew BremenBentley InnoMed GmbH is seeking a qualified professional to manage qualification and validation activities for equipment and computer-based systems. Responsibilities include ensuring compliance with r
Senior QA Specialist cGMP & Validation
Kashiv BioSciences LLCPiscatawaySUMMARY The Quality Assurance Specialist II is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway NJ.This employee will be responsible for supporting Kashiv Bi
Mechanical Product Design & Validation Specialist
SouthwireLargoSpecialist, Engineering - Mechanical Engineering Southwire Company, LLC is one of North America’s largest wire and cable producers, manufacturing building wire, utility products, cable, and electronic
Field Applications Specialist - Instrument Validation & Training
Danaher CorporationHoustonDanaher Corporation is looking for a Sr. Field Applications Specialist based in the United States. This remote role involves validating new Chemistry and Immunoassay instrument installations and colla
Senior Risk Analytics & Model Validation Specialist
6AM CityFloridaCitibank, N.A. is seeking a Model/Analysis/Validation Senior Officer for its Tampa, Florida location. The role involves applying mathematical techniques to address financial issues and managing model
Field Applications Specialist - Instrument Validation & Training
Danaher CorporationDallasDanaher Corporation is seeking a Sr. Field Applications Specialist (FAS) based in Dallas, TX. This role is responsible for validating new Chemistry and Immunoassay instrument installations and providi
Remote Field Applications Specialist- Instrument Validation
RadiometerNew YorkRadiometer is hiring for a position focusing on validating Chemistry and Immunoassay instrument installations, ensuring readiness through collaboration with customers. The ideal candidate should have
Business Analyst & Testing Specialist for Validation & QA
GRMincBloomingtonGRMinc is seeking a Business Analyst with Testing Experience for a 7-month contract in Bloomington, IL. The ideal candidate will have a good understanding of testing processes, tools, and be capable o
QA Validation Technician I
Ageatia Global SolutionsUnited StatesHi, We are looking for aQA Validation Technician I,for the below mentioned job description. Kindly forward me your updated resume, rate and contact details for further process.Job Title: QA Validation
Manager, QA Method Validation
U441 (FCRS = US441) Navigate BioPharma Services, Inc.CarlsbadJob Description Summary Location: Carlsbad, United States. You’ll play a critical role at the intersection of quality, innovation, and patient impact—leading laboratory method validation for assays an
Manager, QA Validation Oversight
Regeneron PharmaceuticalsTroyOverview Regeneron is hiring a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process vali
Senior QA Validation Strategy Lead
Regeneron PharmaceuticalsTroyRegeneron Pharmaceuticals, Inc (USA) is seeking a Manager, QA Validation Oversight to lead a dedicated team focused on maintaining the integrity of process validation activities. This pivotal role inv
Lab Systems QA Engineer – Regulated Validation
Natera, Inc.New YorkNatera, Inc. is seeking a dedicated Software Tester to design, develop, and execute testing strategies in a laboratory environment. This role requires a Bachelor's degree in a scientific discipline an
Sterile Process Validation Lead - QA Oversight
Harba Solutions Inc.FishersHarba Solutions Inc. is seeking a Senior Quality Process Validation Specialist in Fishers, Indiana. The role involves providing QA oversight for process validation activities in the CDMO for sterile i
Senior QA Validation & Compliance Lead (GMP)
Germer InternationalKing of PrussiaGermer International is seeking a Quality Assurance Validation and Compliance Lead in King of Prussia, Pennsylvania. This hands-on role requires strong leadership, expertise in validation processes, a
QA Engineer - AI/ML Validation & Cloud Testing
PowerToFlySheltonPowerToFly is looking for a Quality Engineer to join their team based in Connecticut, United States. The role involves ensuring the quality delivery of applications, conducting thorough testing in bot
Validation Test Lead: OS/Firmware QA & Automation
HCL TechnologiesKingHCL Technologies Limited is seeking a Test Lead in King, North Carolina. The successful candidate will design validation for OS images, firmware, and drivers, and develop automation frameworks in Pyth
QA Audits & Controls Leader (Post-Execution Validation)
Qcells North AmericaTeaneckQcells North America is looking for a QA Audits & Controls Manager to ensure operational processes and vendors are executing correctly. This role will involve post-execution validation while identifyi
QA Tester: SFMC Journeys & SQL Data Validation
Talentzo DelhiNew YorkTalentzo Delhi is looking for a Quality Assurance (QA) Specialist to ensure the functionality of software through comprehensive testing. The role involves performing varied tests such as functional, r
QA Audits & Controls Leader (Post-Execution Validation)
Qcells North AmericaIrvineQcells North America is looking for a QA Audits & Controls Manager to ensure operational processes and vendor compliance. This role involves performing audits, tracking defects, and producing quality
Senior Drone QA & Flight Validation Leader Equity
Teal Drones IncSalt Lake CityTeal Drones in Salt Lake City, UT, is seeking a Senior Quality Assurance Manager to lead end-to-end product validation for drone systems. Responsibilities include managing flight testing operations, d
Hybrid QA Analyst: Manual Testing & API Validation
KinglandFort MyersKingland is seeking a Software Quality Control Analyst who will ensure that features work as promised, maintaining a seamless user experience. The role involves manual test case creation and execution
QA Validation Specialist
- Sanford, Florida, United States
- Sanford, Florida, United States
Über
The ideal candidate possesses strong technical expertise in equipment qualification from a Quality Assurance perspective, combined with excellent communication, collaboration, and problem‑solving skills.
Responsibilities
Represent Quality Assurance in equipment qualification and validation activities.
Review and approve qualification and validation documentation, including:
IQ/OQ Protocols and Reports
SARRs
URSs
Qualification Plans
Lifecycle Documentation
Associated Validation Deliverables
Provide QA oversight throughout the equipment lifecycle, including:
Qualification
Enrollment
Change Management
Decommissioning
Periodic Review Activities
Support Computer System Validation (CSV) activities associated with equipment and laboratory systems.
Participate in cross‑functional meetings and project teams involving QA, QC, Engineering, Technical Services, and Operations.
Support equipment qualification projects and ensure compliance with procedures and regulatory requirements.
Review and approve deviations, investigations, root cause analyses, CAPAs, and effectiveness checks as required.
Provide QA support for technical assessments, triage meetings, robustness initiatives, and project‑related activities.
Escalate quality and compliance concerns appropriately and in a timely manner.
Contribute to project planning, execution, and continuous improvement initiatives.
Qualifications
Bachelor’s Degree in Engineering, Life Sciences, Chemistry, Microbiology, Pharmacy, or related technical discipline.
Minimum 5 years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
Strong experience supporting equipment qualification from a Quality Assurance perspective.
Hands‑on experience with:
IQ/OQ/PQ
Equipment Lifecycle Management
SARR
URS Development and Review
Equipment Enrollment
Equipment Decommissioning
Change Control
Computer System Validation (CSV)
Strong understanding of cGMP regulations and quality systems.
Experience reviewing and approving validation documentation and quality records.
Experience with:
Veeva Vault
Kneat (EDES)
EAMS
TrackWise or similar Quality Management Systems
Knowledge of FDA, EMA, and global regulatory expectations related to validation and qualification.
Strong interpersonal and communication skills.
Ability to work effectively in cross‑functional teams.
Strong organizational and time‑management skills.
Ability to manage multiple priorities in a fast‑paced environment.
Strong analytical, investigation, and problem‑solving abilities.
Flexibility, adaptability, and a collaborative mindset.
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
#J-18808-Ljbffr
Sprachkenntnisse
- English
Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.