Astellas Pharma · 3 hours ago
Specialist, Quality Engineer
Sanford, NC
Full-time
Onsite
Mid, Senior Level
$93K/yr - $146K/yr
5+ years expAstellas Pharma Inc. is a pharmaceutical company dedicated to developing innovative therapies for patients. The Specialist, Quality Engineer will ensure compliant operations are maintained by implementing and assessing quality systems and procedures, while collaborating closely with various departments to meet regulatory expectations.
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
A./B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 5-8+ years of experience or M.S. degree and 3-5+ years of experience in a QA function in a biologics manufacturing facility or equivalent experienced quality professionals with 10+ years relevant quality experience in a biologics manufacturing facility
Strong understanding of FDA, EMA, and ICH regulations and guidelines, as well as industry best practices
Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
Excellent problem-solving skills and experience with root cause investigations and CAPA determination
Critical Quality Thinking skills as well as strong decision-making skills
Advanced computer skills
Off-hour coverage and flexibility may be required
Preferred
Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product)
Experience working in a sterile fill/finish facility
Experience working with Computerized systems, e.g. Microsoft Office, CMMS, TrackWise, EDMS, and Building Management System (BMS)
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
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
2025-12-18
2025-12-17
Company data provided by crunchbase