What are the responsibilities and job description for the Specialist, QA Validation position at Astellas Pharma?
Specialist, QA Validation (Onsite in Sanford, NC)
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 .
The Role
This is an Onsite role in Sanford, NC . The Specialist, QA Validation is responsible for providing quality assurance oversight and support for the commissioning, qualification, and validation (CQV) activities across the site. This role ensures that all validation efforts comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. The position collaborates cross-functionally with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.
Responsibilities
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Category BioPharma QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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 .
The Role
This is an Onsite role in Sanford, NC . The Specialist, QA Validation is responsible for providing quality assurance oversight and support for the commissioning, qualification, and validation (CQV) activities across the site. This role ensures that all validation efforts comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. The position collaborates cross-functionally with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.
Responsibilities
- Provide QA oversight and support for CQV activities including but not limited to equipment, instruments, utilities, clean rooms, computer systems, and manufacturing process.
- Evaluate and approve qualification/validation discrepancies and corrective/preventative actions (CAPAs).
- Provide QA oversight periodic review and lifecycle management activities for validated systems and computerized systems.Support revalidation as required by lifecycle management or change control.
- Review and approve change management documentation including Engineering Change Management, Automation Change Management, and general Change Controls.
- Promote and maintain a strong cGMP quality culture across the organization.
- Ensure adherence to local and global quality standards, regulatory requirements, and industry best practices.
- Participate in internal and external audits, including regulatory inspections (e.g., FDA, EMA, DHHS) and third-party or corporate partner audits.
- Bachelor’s degree in a related scientific or technical discipline with3-5 years of experience in biotechnology or pharmaceutical industryor a Master’s degree and 1-3 years of experience in biotechnology or pharmaceutical industry.
- Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
- Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
- Working knowledge of FDA and EMAregulations 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
- Advanced computer skills
- Off hours coverage and flexibility may be required
- Experience working in a clinical and commercial manufacturing environment (Drug Substance and Drug Product).
- Experience working in a sterile fill/finish facility.
- 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
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Category BioPharma QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
