Astellas Pharma · 2 months ago
Specialist, Quality Engineer
Sanford, NC, 27330, United States
Full-time
Onsite
Mid LevelAstellas Pharma Inc. is a pharmaceutical company committed to developing innovative therapies for patients worldwide. The Specialist, Quality Engineer will oversee the implementation and maintenance of quality systems to ensure compliance with regulatory standards and internal policies.
BiotechnologyHealth CareMedical
Responsibilities
Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements
Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc
Perform Quality oversight of calibration and maintenance programs within the CMMS
Provide Quality oversight of the facility EMS program
Provide Quality oversight of Facility programs such as pest control and access control
Provide Quality review and approval of Engineering drawings within the Engineering EDMS
Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports
Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations
Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls
May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records
Define, track, and report quality metrics relevant to job responsibilities
Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed
May perform other quality assurance activities and responsibilities as assigned
Qualification
Required
Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements
Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc
Perform Quality oversight of calibration and maintenance programs within the CMMS
Provide Quality oversight of the facility EMS program
Provide Quality oversight of Facility programs such as pest control and access control
Provide Quality review and approval of Engineering drawings within the Engineering EDMS
Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports
Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations
Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls
May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records
Define, track, and report quality metrics relevant to job responsibilities
Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed
May perform other quality assurance activities and responsibilities as assigned
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
Founded in 2005
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase