Validations Contractor

1 week ago

durham, United States TalentBurst, Inc. Full time

Validations - GMP Quality Assurance Engineer, Research Triangle Park, NC
6 months+
Description:
The Validations Contractor – GMP Quality Assurance, reporting to the Director, GMP Quality Assurance, will be responsible for assisting in the management of Quality Management System (QMS) and will strongly support the Culture of Quality. This role will ensure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 15% of the time) 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 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.


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.
• 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.
• 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.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
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