QA Contractor, GMP Quality Assurance
Lancesoft
Research Triangle Park, NC
Job Responsibilities:
- Manage assigned day-to-day QA responsibilities in support of the company’s Product Quality systems.
- Provide timely support for Third Party Deviations, Third Party Change Controls, and Vendor Management (qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers) activities. Liaison with applicable department record owners to ensure their complete and timely resolution.
- Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues, as needed.
- Communicate project status to stakeholders and escalate issues in a timely manner.
- Perform daily customer-facing activities, as assigned by area management.
- Perform and support other duties as assigned by area management.
- Bachelor’s degree in a scientific field and 2+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 5+ years of GMP based Quality Assurance experience using a company QMS.
- 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 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.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.).
About the Company
Lancesoft
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.