Comrise · 21 hours ago
QA - Computerized Systems Validation (CSV) - Remote
United States
Contract
Remote
Senior Level
$43/hr - $47/hr
5+ years expComrise is seeking a Senior Quality Control Specialist to oversee quality control and assurance of software, process, and data integrity validation processes. The role involves providing guidance to operational teams to ensure compliance with regulatory requirements and conducting reviews of validation lifecycle documents.
Staffing & Recruiting
Hiring Manager
Chester Floyd Canono
Responsibilities
Provides guidance to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversees quality activities related to software, process, and data integrity validation
Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy
Provides quality guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
Conducts and/or assists with periodic review of system documentation according to defined schedule to ensure continued compliance with SOPs, corporate policies, standards, and government regulations
Provides quality review and approval of change request documentation related to changes that impact validated systems and/or processes
Supports the preparation, hosting, and follow-up of Sponsor audits/assessments and regulatory inspections where necessary
Participates in the development and/or review of IT standards, policies, procedures, work instructions, forms, and templates to support the QMS
Educates, trains, and mentors staff in QMS processes and quality improvement methods
Attends training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends
Participates or leads divisional improvement efforts. Performs related work as requested
Stays abreast of final FDA regulations and guidance documents ensuring compliance
Reviews draft guidance documents assessing existing validation processes to identify potential changes to the validation process. Works with Director and Consulting Validation Engineer to implement process changes for compliance with updated/future regulatory guidance documents
Performs other duties as assigned
Mandatory: The following are mandatory expectations of all employees
Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement.”
During your employment, you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date
Qualification
Required
Knowledge of FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines
Knowledge of pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principles
Professional demeanor and positive attitude; excellent communication and inter-personal skills
Strong analytical skills, attention to detail, writing and documentation skills and a passion for quality
The ability to work as part of a cross-disciplinary team and relate to a diverse number of co-workers
Ability to define, learn, understand, and apply new technologies, methods, and processes
Good time management and organization skills
Bachelor's Degree
5+ years of experience
Preferred
Knowledge of EU regulations, e.g., Annex 11 is helpful
Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc. is helpful
Company
Comrise
Headquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company.
Founded in 1984Woodbridge Township, New Jersey, US
1001-5000 employees
H1B Sponsorship
Comrise has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (11)
2023 (9)
2022 (7)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Dana N.
Director MSP Strategic Partnerships
Company data provided by crunchbase