Astellas Pharma · 4 days ago
Specialist, Quality Assurance for QC
Sanford, NC
Full-time
Onsite
Mid, Senior Level
$93K/yr - $146K/yr
5+ years expAstellas Pharma is a global pharmaceutical company committed to developing innovative therapies for patients. The Specialist, Quality Assurance for QC will provide direct oversight and support for Quality Control operations, ensuring compliance with regulations and best practices while collaborating with cross-functional teams.
BiotechnologyHealth CareMedical
Responsibilities
Provide QA oversight of QC laboratory activities, including testing of raw materials, in-process samples, drug substance and drug product, and environmental monitoring
Conduct routine area walkthroughs to ensure laboratories operate in a state of control and comply with current Good Manufacturing Practices (cGxP)
Oversee the qualification, validation, and transfer of analytical methods, critical reagents, and reference standards
Review and approve associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards
Serve as a Subject Matter Expert (SME), providing advanced technical guidance and troubleshooting support for complex laboratory and quality-related issues
Make informed decisions with minimal guidance, proactively seeking input when addressing cross-functional challenges
Assist in workload management by prioritizing and distributing tasks across the team to ensure efficient execution of responsibilities
Review and authorize laboratory testing data within Laboratory Information Management Systems (LIMS)
Review and approve Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support batch disposition
Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements
Lead or support nonconformances and deviations related to QC processes, including laboratory investigations, Out of Specification (OOS), and Out of Trend (OOT) results
Author, review, and approve controlled documents such as Standard Operating Procedures (SOPs), specifications, protocols, and reports for Quality and GMP-related functions
Author, review, and approve Quality System records, including Nonconformances, Corrective and Preventive Actions (CAPAs), and Change Management documentation, with thorough causal and impact assessments
Qualification
Required
Bachelor's degree in a related scientific or technical discipline with 5-8+ years of experience in biotechnology or pharmaceutical industry or a Master's degree and 3-5+ years of experience in biotechnology or pharmaceutical industry
Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality Control environment
Strong knowledge of Quality Control laboratory operations and systems
Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and 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
Off hours coverage and flexibility may be required
Preferred
Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product)
Knowledge and experience within a Quality Control discipline and/or method validation
Experience working in a Laboratory Information Management system
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
2026-01-07
Company data provided by crunchbase