QA Validations Analyst

• 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 Quality Management System (QMS) and will strongly support Culture of Quality. The position will be based at our headquarters facility in RTP, NC with no travel expected.

• 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; equipment and computer system qualification and validation documents, SOPs, Change Controls, non-conformities, Deviations 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 QMS and GMPs, including:

• Support equipment and computer system qualification and validation activities and vendor management program.
• Review and approve SOP drafts and revisions.
• Support, review and approve assigned change control records.
• 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.

• 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).

akarsh.yathiraj@leadstackinc.com