Sr. IT QC Specialist
Nashville , TN
Experience: 0
Category: Information Technology
Contractor Work Model: Remote
Brand: Joulé
Compensation Range: 47.50 Per Hour
Job ID: 346530
Date Posted: 02/19/2026
Shortcut: http://jobs.systemone.com/0iLi3t
Job Title: Senior IT Quality Control Specialist – CSV/CSA
Location: 100% Remote (CST preferred)
Hours/Schedule: Monday–Friday, standard business hours
Compensation: $43-47/hour DOQ
Type: Contract (12 months)
Overview
The Senior IT Quality Control Specialist provides QA oversight for computerized systems validation (CSV), remediation initiatives, and software quality processes within a regulated environment. This role ensures compliance with FDA CSA principles, GxP requirements, and global regulatory standards while partnering cross-functionally with IT, validation, and operational teams. The ideal candidate is a detail-oriented quality professional with strong regulatory knowledge and hands-on validation lifecycle experience.
Responsibilities
-
Provide QA oversight for computerized systems validation (CSV), remediation initiatives, and data integrity programs
-
Interpret and apply FDA GxP, 21 CFR Part 11, and CSA guidance to validation and quality management processes
-
Review validation lifecycle documentation including validation assessments, Part 11 assessments, validation plans, risk assessments, and summary reports
-
Provide quality guidance for IQ, OQ, and PQ protocol preparation, execution, data analysis, and reporting
-
Conduct periodic reviews of validated systems to ensure continued compliance with SOPs and regulatory requirements
-
Review and approve change control documentation impacting validated systems and processes
-
Support sponsor audits, regulatory inspections, and quality assessments, including preparation and follow-up activities
-
Contribute to development and revision of IT standards, policies, procedures, templates, and QMS documentation
-
Educate and mentor staff on validation processes, quality systems, and regulatory expectations
-
Monitor emerging FDA guidance and industry standards; assess impact and support implementation of process updates
-
Collaborate with validation engineers, business owners, and IT stakeholders to ensure compliant and efficient system validation practices
Qualifications
Required:
-
Bachelor’s degree (Master’s preferred) in a scientific, technical, or related discipline
-
5+ years of experience in QA oversight within computerized systems validation (CSV)
-
Hands-on experience conducting periodic reviews of validated systems
-
Strong working knowledge of FDA Computer Software Assurance (CSA) principles
-
In-depth knowledge of FDA GxP requirements, 21 CFR Part 11, and software validation guidelines
-
Experience supporting remediation initiatives in regulated environments
-
Strong analytical, documentation, and technical writing skills
Preferred:
-
Knowledge of EU Annex 11 requirements
-
Familiarity with GAMP 5, PIC/S, ICH, and other international software quality standards
-
Experience in pharmaceutical, biologics, CRO, or medical device environments
-
Demonstrated ability to mentor and guide cross-functional teams on validation and compliance best practices
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #568-Clinical
-
QA Associate
Morristown, New Jersey
Job Title: QA Associate Location: Florham Park area (Hybrid) Hours / Schedule: 9am - 5pm Type: Direct Hire The QA Associate will support Quality and Regulatory functions by coordinating technical documentation and managing sampling activities (NON-LAB)...
Date Posted: 02/13/2026 Recommended
-
Technical Writer
Oro Valley, AZ
Job Title: Technical Writer Location: Remote (candidates local to Tucson, AZ preferred) Pay Range: $30.00 - $35.00/hr Type: Contract, Potential for extension or conversion to permanent Formatted Job Description: The Technical Writer is responsible for ...
Date Posted: 01/28/2026 Recommended
-
Quality Assurance / Regulatory Affairs (QA/RA) Manager
Jersey City, New Jersey
QA/RA Manager - Medical Device Manufacturing (PRP Products) Location: Jersey City, NJ Employment Type: Direct Hire Compensation: $100,000 – $130,000 annually Schedule: On-site, Monday–Friday Reports to: President & CEO About the Role This role is with ...
Date Posted: 02/03/2026 Recommended
-
OMICS Laboratory Lead/Manager II
Pittsburgh, PA
Title: OMICS Laboratory Manager II Location: Onsite, Pittsburgh, PA 15219 Type: 6-month contract to hire Hours: 8AM-5PM Start: Immediately Overview: Join as a Laboratory Manager II to monitor personnel and workflow in the area. Track and monitor QA/QC ...
Date Posted: 02/12/2026 Recommended
-
Process Mechanic
Exton, PA
Job Title: Process Mechanic Location: Exton, PA Type: Contract Overview The Process Mechanic is responsible for monitoring, operation, performing preventive maintenance and corrective maintenance of GMP and non-GMP utilities and HVAC equipment as well ...
Date Posted: 02/24/2026 Recommended
-
Quality Engineer
Orville, Ohio
Job Title: Quality Engineer Location: Orville, Ohio Type: Contract To Hire We are seeking a dedicated and detail-oriented Quality Engineer in Orrville, OH. This full-time position offers an exciting opportunity for an experienced professional to contri...
Date Posted: 02/12/2026 Recommended
-
Quality Assurance Compliance Specialist
Bethlehem, Pennsylvania
Job Title: Quality Assurance Compliance Specialist Location: Bethlehem, Pennsylvania Hours: 2nd shift (approx. 3:00 PM – 11:30 PM; some flexibility) Type: Direct Hire Compensation: $70000 - $75000 annually Position Overview: Our client is seeking a Qua...
Date Posted: 02/20/2026 Recommended
-
I&C Manufacturing Engineer
Corvillas, OR
Job Title: Remote I&C Manufacturing Engineer Location: Corvallis, OR Type: Direct Hire Salary: $111,000 – $134,000 Work Model: Remote with 10–25% travel System One is seeking an I&C Manufacturing Engineer to support nuclear instrumentation and control ...
Date Posted: 02/23/2026 Recommended
-
Senior Manager, Engineering Plastics Processing
Lakewood, Colorado
Job Title: Senior Manager, Engineering Plastics Processing Location: Onsite - Lakewood, CO (RELOCATION Package available) Type: Direct Hire Salary Range: $160,000 to $200,000/year, 20% target bonus Position Overview The Senior Manager of Engineering Pl...
Date Posted: 02/09/2026 Recommended
-
Ingredient Compliance Specialist
Parsippany, New Jersey
Job Title: Ingredient Compliance Specialist Type: Direct Hire Location: Morris County, NJ (Whippany/Parsippany, NJ) Schedule: Hybrid | 9:00 a.m.–5:00 p.m. Salary: $70,000–$85,000 + performance bonus Requirements BS degree in Science 3–5 years of Qualit...
Date Posted: 02/18/2026 Recommended
-
Hardware Engineer I
Arlington, TX
Job Title: Hardware Engineer Location: Arlington, TX (onsite) Type: Contract Compensation: $34.00 hourly Security Clearance: Active Secret clearance required. (Must be able to obtain an NRC Public Trust Security Clearance before starting which may take...
Date Posted: 02/24/2026 Recommended
-
Senior Safety Verification and Validation Engineer
Bellevue, Washington
Job Title: Senior Safety Verification and Validation Engineer Type: Contract (12-months) Contractor Work Model: Remote About the Role: As a Senior Safety V&V Engineer, you will be instrumental in verifying and validating safety assessment models and so...
Date Posted: 02/23/2026 Recommended
-
PMA Expert
jersey city, New Jersey
PMA Expert Location: Jersey City, NJ Type: Direct Hire Compensation: $150,000 – $170,000 annually Work Model: Onsite, First Shift (9 AM – 5 PM) Position Overview We are seeking a highly accomplished PMA Expert with deep expertise in FDA-regulated medic...
Date Posted: 02/25/2026 Recommended
-
Senior Marine Electrical Manager
North Kingstown, Rhode Island
Summary Statement The Senior Maritime Electrical Manager provides leadership and technical oversight for the design, integration, and delivery of shipboard electrical systems supporting new vessel construction and refit projects. This role oversees ele...
Date Posted: 02/23/2026 Recommended
-
Drainage Engineer
Guaynabo, Puerto Rico
Job Title: Drainage Engineer Location: Guaynabo, Puerto Rico Type: Direct Hire Compensation: $72000 - $93000 annually Contractor Work Model: Onsite System One is actively seeking a Drainage Engineer for a direct hire opportunity with a client in Guayna...
Date Posted: 01/20/2026 Recommended
-
Principal Investigator - Dermatology North Carolina
concord, North Carolina
Job Title: Clinical Research Physician (Dermatology, PRN) Location: Concord, NC Engagement: PRN / Contract ( approx. 5–10 hours per week) Overview Seeking a US Board Certified Dermatologist, who can function as a Clinical Principal Investigator (PI). T...
Date Posted: 01/02/2026 Recommended
-
OMICS Laboratory Lead/Manager II
Pittsburgh, PA
Title: OMICS Laboratory Manager II Location: Onsite, Pittsburgh, PA 15219 Type: 6-month contract to hire Hours: 8AM-5PM Start: Immediately Overview: Join as a Laboratory Manager II to monitor personnel and workflow in the area. Track and monitor QA/QC ...
Date Posted: 02/20/2026 Recommended
-
Environmental and Seismic Engineer
Oak Ridge, Tennessee
Environmental & Seismic Engineer – Oak Ridge, TN (Onsite) Type: Direct Hire Work Model: Onsite (Relocation assistance not provided) System One is seeking an experienced Environmental and Seismic Engineer to support nuclear facility programs in Oak Ridg...
Date Posted: 02/12/2026 Recommended
-
Packaging Technician - 3rd Shift
Athens, GA
Job Title: Packaging Technician (3rd Shift) Location: Athens, GA Hours/Schedule: Monday–Friday, 11:00 pm to 7:00 am Compensation: $20/hour Type: 6 month contract Packaging Technician (3rd Shift) Performs labeling, inspection, and packaging of finished ...
Date Posted: 02/18/2026 Recommended
-
Packaging Technician - 2nd Shift
Athens, GA
Job Title: Packaging Technician (2nd Shift) Location: Athens, GA Hours/Schedule: Monday–Friday, 2:30 pm to 11:00 pm Compensation: $18 to $20/hour Type: 6 month contract Packaging Technician (2nd Shift) Performs labeling, inspection, and packaging of fi...
Date Posted: 02/18/2026 Recommended
-
Operations Support Specialist 3
Los Alamos, New Mexico
Job Title: Operations Support Specialist 3 Location: Los Alamos, New Mexico Security Clearance: Active DOE Q Clearance Required Schedule: Full-time, 40 hours per week Contract Period: February 23, 2026 – February 23, 2028 Positions Available: 4 Positio...
Date Posted: 02/13/2026 Recommended
-
Director of Engineering Operations
Morgantown, West Virginia
Job Title: Director of Engineering Operations Location: Morgantown, WV Type: Direct Hire Compensation: Contractor Work Model: Onsite Director of Engineering Operations *Relocation Assistance Available Objective Lead engineering operations for a food ma...
Date Posted: 01/28/2026 Recommended
-
I&C Design Engineer
Bellevue, WA
Job Title: Design Engineer Type: Contract Compensation: $52 - $85 hourly Contractor Work Model: Remote Overview: We are seeking a talented and experienced Design Engineer specializing in Instrumentation and Control (I&C) for a contract opportunity with...
Date Posted: 01/05/2026 Recommended
-
I&C Design Engineer Lead
Bellevue, WA
System One is seeking an experienced Instrumentation & Controls (I&C) Design Engineer to support advanced nuclear reactor development. This contract position supports system design, prototype development and testing, plant-level system integration, and...
Date Posted: 02/23/2026 Recommended
-
QC Chemist
Cranbury, NJ
Job Title: QC Chemist Location: Cranbury, NJ Hours / Schedule: Standard business hours; overtime may be required based on project deadlines Type: Contract to Hire with strong intent to convert for the right candidate Compensation: $35 - $36 per hour (s...
Date Posted: 01/09/2026 Recommended
-
Mechatronics Engineer III
Littleton, CO
Job Title: Mechatronics Engineer III Location: Littleton, CO Type: Direct-Hire Compensation: $105,000-$130,000/year, 7% bonus eligible Contractor Work Model: On-site Hours: 40 hours/week M-F Day Overview: Global Medical Device Company is hiring a Mecha...
Date Posted: 02/19/2026 Recommended
-
Director, Regulatory Strategy (Medical Devices)
Lakewood, CO
Director of Regulatory Strategy (Medical Devices) Medical Device | Global Scope | Denver Metro (Hybrid) Compensation: $195,000–$245,000 base + 30% target bonus (Compensation aligned to experience, scope, and market benchmarks.) The Opportunity A well-e...
Date Posted: 02/13/2026 Recommended
-
Full Stack Developer
Merrifield, VA
Job Title: Senior Full Stack Developer (C#/.Net, React, JS) Location: Vienna, VA Work model: hybrid, 2-3 days onsite Pay Rate: Open to W2, established 1099's, and c2c (H1 candidates only) options Position Type: Multiyear Contract This role requires som...
Date Posted: 02/25/2026 Recommended
-
Production Operator
Orangeburg, NY
Job Title: Production Technician I Location: Orangeburg, NY Start Date: ASAP! Duration: 6+ Month Contract (possible Contract-to-Hire) Hours: Monday-Friday; 3rd shift 11:00pm-7:30am Pay : $20-$23/hour depending upon experience Experience/"MUST HAVES": M...
Date Posted: 01/10/2026 Recommended
-
Qualys Vulnerability Management Analyst
Rockville, Maryland
Job Title: Qualys Vulnerability Management Analyst Location: Rockville, Maryland Type: Contract Compensation: $45 - $55 hourly Contractor Work Model: Hybrid Overview: The organization is expanding its Vulnerability Management program and is seeking a h...
Date Posted: 02/25/2026 Recommended