Validation - GMP Quality Assurance

IntelliPro Group Inc.

10d•Onsite

About The Position

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.

Requirements

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.
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).

Nice To Haves

3+ years of onboarding, qualification, and validation of equipment, instruments, and computerized systems, is preferred.

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.