Validation - GMP Quality Assurance at IntelliPro Group Inc.

, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Aug, 26

Salary

55.0

Posted On

03 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Quality Assurance, Equipment Validation, Computerized Systems Validation, Change Control, SOP Development, CAPA, Quality Management System, Regulatory Compliance, Technical Writing, Vendor Management, Data Review, Project Management, Microsoft Office Suite, Trackwise, ZenQMS, Veeva

Industry

Staffing and Recruiting

Description

Job Title: Validations Contractor – GMP Quality Assurance Duration: 05-11-2026--- 12-21-2026 with possible extension Office: Research Triangle Park, NC 27709 Pay rate: $55/hr. on W2 Summary: The Validations Contractor – GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against corporate procedures, and applicable GMP national, international, and state regulations. Acting as a key QA partner to technical and operational teams, this role will provide expert oversight and quality support throughout the lifecycle of validation activities, from planning and development through execution and final approval. This role will assist in the management of client’s Quality Management System (QMS) and will strongly support client’s Culture of Quality. The position will be based at our headquarters facility in RTP, NC with no travel expected. Job Responsibilities: Work alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding. Provide timely quality support and thorough reviews and approvals of various records including, but not limited to Change Controls; SOPs; analytical method, equipment and computer system qualification and validation plans, protocols, and summary reports; batch records; QC data; non-conformities and Corrective Action/Preventive Action (CAPAs). Ensure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management. Report on applicable key metrics to drive continuous improvement in compliance. Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities. Maintain Quality Systems in support of client’s QMS and GMPs, including: Review and approve SOP drafts and revisions. Process change controls. Support equipment and computer system qualification and validation activities and vendor management program. Communicate project status to stakeholders and escalate issues in a timely manner. Support ongoing Computerized Maintenance Management System records, including review and approval of work order records. About You: Bachelor’s degree in a scientific field. 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing. 3+ experience working within a pharmaceutical/biotech electronic Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement. 3+ years of onboarding, qualification, and validation of equipment, instruments, and computerized systems, is preferred. Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards. Strong technical understanding of equipment and system validation principles. Ability to author, review, and interpret Standard Operating Procedures (SOPs). Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner. Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment. Ability to manage workload effectively in order to meet project timelines. Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues across a dynamic GMP environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). About Us: Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU. IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.

Responsibilities

The contractor will ensure the compliant onboarding, qualification, and validation of equipment and computerized systems according to GMP regulations. They will also provide quality oversight, review documentation such as SOPs and CAPAs, and support the site's Quality Management System.