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Validation Specialist
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Randstad USA
Marion, NC (In Person)
$90,948 Salary, Full-Time
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Job Description
job summary: Our Client is seeking a driven Validation Specialist in Marion, NC to help redefine healthcare and save and sustain lives. In this role, you will validate cutting-edge medical device and pharma operations by leveraging your expertise in Kneat Gx, FDA regulations, and
Author, route, and manage validation documentation strictly within KNEAT Gx, ensuring end-to-end traceability and 21 CFR Part 11 data integrity compliance.
Guarantee all deliverables meet FDA c
Investigate validation deviations, assess change control impacts, and drive root cause analysis to maintain system integrity.
Partner with Engineering, Quality, IT, and Operations to provide dynamic on-floor support for commissioning, line upgrades, and new equipment introductions.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. job detailssummary$34.98 - $52.47 per hourcontractbachelor degreecategorycomputer and mathematical occupationsreference1109188job details job summary: Our Client is seeking a driven Validation Specialist in Marion, NC to help redefine healthcare and save and sustain lives. In this role, you will validate cutting-edge medical device and pharma operations by leveraging your expertise in Kneat Gx, FDA regulations, and
Author, route, and manage validation documentation strictly within KNEAT Gx, ensuring end-to-end traceability and 21 CFR Part 11 data integrity compliance.
Guarantee all deliverables meet FDA c
Investigate validation deviations, assess change control impacts, and drive root cause analysis to maintain system integrity.
Partner with Engineering, Quality, IT, and Operations to provide dynamic on-floor support for commissioning, line upgrades, and new equipment introductions.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.
ISO 13485
standards.location:
Marion, North Carolina job type: Contract salary: $34.98 - 52.47 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Perform hands-on IQ, OQ, PQ, and requalification activities for manufacturing equipment, utilities, and computerized systems using risk-based methodologies.Author, route, and manage validation documentation strictly within KNEAT Gx, ensuring end-to-end traceability and 21 CFR Part 11 data integrity compliance.
Guarantee all deliverables meet FDA c
GMP, ISO
13485, and internal QMS standards to maintain a state of continuous inspection and audit readiness.Investigate validation deviations, assess change control impacts, and drive root cause analysis to maintain system integrity.
Partner with Engineering, Quality, IT, and Operations to provide dynamic on-floor support for commissioning, line upgrades, and new equipment introductions.
qualifications:
Experience level:ExperiencedEducation:
Bachelors skills:ValidationQualityAutomationMedical Device Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. job detailssummary$34.98 - $52.47 per hourcontractbachelor degreecategorycomputer and mathematical occupationsreference1109188job details job summary: Our Client is seeking a driven Validation Specialist in Marion, NC to help redefine healthcare and save and sustain lives. In this role, you will validate cutting-edge medical device and pharma operations by leveraging your expertise in Kneat Gx, FDA regulations, and
ISO 13485
standards.location:
Marion, North Carolina job type: Contract salary: $34.98 - 52.47 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Perform hands-on IQ, OQ, PQ, and requalification activities for manufacturing equipment, utilities, and computerized systems using risk-based methodologies.Author, route, and manage validation documentation strictly within KNEAT Gx, ensuring end-to-end traceability and 21 CFR Part 11 data integrity compliance.
Guarantee all deliverables meet FDA c
GMP, ISO
13485, and internal QMS standards to maintain a state of continuous inspection and audit readiness.Investigate validation deviations, assess change control impacts, and drive root cause analysis to maintain system integrity.
Partner with Engineering, Quality, IT, and Operations to provide dynamic on-floor support for commissioning, line upgrades, and new equipment introductions.
qualifications:
Experience level:ExperiencedEducation:
Bachelors skills:ValidationQualityAutomationMedical Device Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.