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/sCMmSE
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: 03/23/2026 Recommended
-
Graphic Designer/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: 03/12/2026 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: 03/10/2026 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: 03/17/2026 Recommended
-
Quality Engineer
Orangeburg, NY
Job Title: Quality Engineer Location: Greater Orangeburg / Blauvelt, NY area Duration: Contract 4-6 months Schedule: Mon–Fri, 8 hour days (100% onsite) Pay Rate: $38–43/hr Start Date: ASAP Role Overview This organization is a global leader in specializ...
Date Posted: 03/17/2026 Recommended
-
Regulatory Affairs Labeling Operations Specialist
Plansboro, New York
Job Title: Labeling Specialist Location: Plainsboro Township, New Jersey Compensation: $100k-120k annually, FTE + 20 days of PTO + 10 Holidays - 401k benefits/etc. Open to discuss higher salaries with candidates meeting and exceeding requirements. Work...
Date Posted: 03/05/2026 Recommended
-
Manufacturing Production Supervisor
Fort Stockton, Texas
Job Title: Manufacturing Production Supervisor Location: Fort Stockton, Texas Type: Contract To Hire Compensation: $33 - $35 hourly Contractor Work Model: Onsite Position Overview The Facility / Site Supervisor is a critical leadership role at a Therma...
Date Posted: 03/02/2026 Recommended
-
Learning & Development Associate
Indianapolis, IN
Job Title: Learning & Development Associate Location: Indianapolis, IN Pay Range: $35.00 - $43.80/hr Type: Contract, Potential for extension or conversion to permanent Overview The Global Quality Implementation Specialist is an individual contributor r...
Date Posted: 03/13/2026 Recommended
-
QA Specialist
Andover, MA
Job Title: QA Specialist Location: Andover, MA Type: Contract Compensation: $46.88 Contractor Work Model: Hybrid – onsite and remote Hours: 40.0 Overview Leading pharmaceutical company looking for an experienced QA Specialist. Ideal candidates should h...
Date Posted: 03/23/2026 Recommended
-
Senior Manager, Engineering Plastics Processing
Lakewood, Colorado
Job Title: Senior Manager, Engineering Plastics Processing - Extrusion 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 En...
Date Posted: 03/03/2026 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: 03/03/2026 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
-
API EM Quality Assurance Associate
Indianapolis, IN
Job Title: API EM Quality Assurance Associate Location: Indianapolis, IN Compensation: $50 - $57.10/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities Serve as a liaison between Contract Managers (CMs) and company, p...
Date Posted: 03/13/2026 Recommended
-
Quality Assurance Associate
East Windsor, NJ
Job Title: Quality Assurance Associate Location: East Windsor, NJ Type: Contract To Hire Compensation: Pay Rate – hourly: $30–$40/hr Contractor Work Model: Onsite Hours: 40.0 Responsibilities Ensure cGMP compliance across all project and product-relate...
Date Posted: 03/18/2026 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: 03/09/2026 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: 03/12/2026 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
-
Pharmacy Technician
Indianapolis, IN
Job Title: Pharmacy Technician Location: Indianapolis, IN Hours: Mon - Fri 8am - 5pm Max Pay Rate: $25.00/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities We are seeking a detail-oriented and dependable Pharmacy Te...
Date Posted: 03/12/2026 Recommended
-
Environmental and Seismic Engineer
Oak Ridge, Tennessee
Environmental & Seismic Engineer – Oak Ridge, TN Type: Direct Hire Work Model: Onsite System One is seeking an experienced Environmental and Seismic Engineer to support nuclear facility programs in Oak Ridge, TN. This role is essential to ensuring safe...
Date Posted: 03/02/2026 Recommended
-
Quality Auditor III
Andover, MA
Job Title: Quality Auditor - III Location: Andover, MA Type: Contract Compensation: $59.50 Contractor Work Model: Remote – offsite Hours: 40.0 Overview Leading pharmaceutical company looking for an experienced Quality Auditor III. This role is mostly r...
Date Posted: 03/23/2026 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
-
Senior Manager, Technical Operations – Fermentation/Chemistry
Lake Forest, Illinois
Job Title: Senior Manager, Technical Operations – Fermentation/Chemistry Location: Lake Forest, Illinois Type: Direct Hire Compensation: $152,000 - $182,000 annually Contractor Work Model: Hybrid Hours: 40.0 Security Clearance: Not specified in the job...
Date Posted: 03/18/2026 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
-
Solar Specialist
Cleveland, Mississippi
Job Title: Solar Specialist (Owner’s Representative / Site Representative) Location: Cleveland, Mississippi Type: Contract Work Model: Onsite Duration: ASAP Per Diem: $178/day Position Overview System One is seeking an experienced Solar Specialist (Own...
Date Posted: 03/12/2026 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
-
Bus Systems Analyst Lead
Farmers Branch, TX
Title: Business Systems Analyst Lead Position Location: Dallas, TX/Pittsburgh, PA/ Cleveland, OH - 5 Days Onsite Function of the Group: Mitigates Risk Initiatives/Projects: The resource will assist with ongoing change requests, automation enhancements,...
Date Posted: 03/09/2026 Recommended
-
Quality Assurance
Pittsburgh, PA
Position Title: Quality Assurance Location: Pittsburgh, PA Industry background: Finance or Banking is a plus Team Dynamic: working within an agile QA test team. Roles and Responsibilities: Create and conduct API requests, collections, and environments ...
Date Posted: 03/23/2026 Recommended