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QA Contractor, GMP Quality Assurance
Research Triangle Park, NC 00277
Job Description
Job Responsibilities:
- Manage assigned day-to-day QA responsibilities in support of the company’s Quality Management Systems (QMS).
- Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS based customer requests. Liaison with applicable department record owners to ensure their complete and timely resolution. Review and Approve said record types as assigned.
- Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.
- Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues;Draft SOPs/controlled documents as well as perform quality unit review and approval of Quality Management Systems requests/ records related to Learning Management, Non-Conformance Management, CAPA management, and metric/KPI reporting.
- Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.
- Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.
- Perform daily customer-facing activities, as assigned by area management. Maintain health of customer-facing activities such as document archival activities and notebook/logbook assignment and management.
- Identify and collaborate with colleagues to implement continuous improvement initiatives;provide Quality Unit oversight of QMS based activities.
- Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.
- Support regulatory (FDA, EMA) and internal audits/inspections per the company’s procedures and applicable regulatory requirements.
- Communicate project status to stakeholders and escalate issues in a timely manner.
- Perform and support other duties as assigned by area management.
- Bachelor’s degree in a scientific field and 4+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 10+ years of GMP based Quality Assurance experience using a company QMS.
- 3+ experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement
- Strong 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.
- Strong service-oriented mindset with excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
- Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.