QA Contractor, GMP Quality Assurance

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

For further inquiries about this opportunity please contact our Talent Specialist Hema at

Title: QA Contractor GMP Quality Assurance
Duration: 12 Months
Location: Research Triangle Park NC

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Description:

The QA Contractor GMP Quality Assurance reporting to the Director GMP Quality Assurance or designee. This role will assure 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 10% of the time) expected.

Job Responsibilities

Manage assigned day-to-day QA responsibilities in support of the companys 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.

About you

Bachelors 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 us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.

For further inquiries about this opportunity please contact our Talent Specialist Hema at Title: QA Contractor GMP Quality Assurance Duration: 12 Months Location: Research Triangle Park NC Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considere...