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Location
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Durham, NC 27712

Full Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our Company is expanding its global (HPV) vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps. Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines.

The Quality Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities supporting the HPV expansion facility.

GENERAL PROFILE:

Position will initially be M-F first shift transitioning to rotational including holidays. Flexibility to work night shift is required.

Ability to work independently and as a member of a team.

Contributes to the performance and results of the expansion project.

Adapts plans and priorities to address resource and operational challenges.

Decisions are guided by policies, procedures and/or business plans and aligns with management.

Provides quality guidance to employees, colleagues or clients.

Anticipates and interprets client and/or customer needs to identify solutions.
Durham, NC 27712 Full Job Description Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Our Company is expanding its global (HPV) vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps. Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our Company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded HPV vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our HPV vaccines. The Quality Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities supporting the HPV expansion facility. GENERAL PROFILE: Position will initially be M-F first shift transitioning to rotational including holidays. Flexibility to work night shift is required. Ability to work independently and as a member of a team. Contributes to the performance and results of the expansion project. Adapts plans and priorities to address resource and operational challenges. Decisions are guided by policies, procedures and/or business plans and aligns with management. Provides quality guidance to employees, colleagues or clients. Anticipates and interprets client and/or customer needs to identify solutions.
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