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Specialist, Quality Assurance for QC

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose and Scope:

The **Specialist, Quality Assurance for QC** will be responsible for providing direct Quality oversight and support for Quality Control and US Methods and Tech Transfer laboratory operations and method qualification activities. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This role will collaborate with cross-functional teams such as other Quality Assurance, Validation, Manufacturing, and MSAT teams to ensure quality and compliance.

Essential Job Responsibilities:

Quality Oversight of Laboratory Operations:

+ 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).

Test Method and Material Lifecycle Management:

+ 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.

Technical Leadership and Support:

+ 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.

Data and Documentation Review:

+ 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.

Quality Systems and Compliance:

+ 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.

Qualifications

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

Working Environment:

+ This position is based at Astellas in Sanford, NC and will require on-site work in a cGMP regulated manufacturing facility (80-100%).

+ On occasion, this role may travel to other Astellas facilities (0-5%).

+ Flexible grade level based on candidate background and skillset.

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

+ Referral bonus program

\#LI-TD

Category BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans