QC Senior Analyst (FTC 18 months)

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Job Description

Job Purpose

The Quality Control (QC) Specialist will support all laboratory-based QC activities related to Analytical Method Transfer (AMT) in support of New Product Introductions (NPI). This role ensures compliance with applicable regulatory requirements, company standards, and procedures at the Grange Castle Small Molecules site.

The position is a fixed term role for 18 months.

Key Responsibilities :

Analytical Method Transfer & Validation

• Support method validation review and gap assessments
• Author and review AMT protocols and final reports
• Coordinate and support protocol execution and testing
• Provide direct support to QC analysts during method transfer execution
• Review QC batch data and ensure accuracy and compliance

Quality Systems & Documentation

• Draft, review, and update QC SOPs and analytical test methods
• Complete Laboratory Investigations (e.g., OOS, OOT), deviations, and CAPAs
• Ensure all QC documentation is in line with data integrity requirements

Operational & Technical Support

• Serve as Subject Matter Expert (SME) for laboratory operations supporting NPI
• Troubleshoot general laboratory systems and methods
• Support raw material inspection specifications and pharmacopoeial reviews
• Ensure laboratory equipment maintenance and calibration
• Provide laboratory scheduling support and exception-based testing

Training & Collaboration

• Deliver training for QC personnel where applicable
• Collaborate with cross-functional teams including QA, IT, and Manufacturing
• Contribute to audit preparation (HPRA, FDA, corporate, and client)

Continuous Improvement & Safety

• Support the implementation of new QC technologies
• Promote and maintain a strong safety culture in the lab environment
• Investigate and report non-conformances or incidents in a timely manner

General Responsibilities

• Actively participate in cross-functional training initiatives
• Promote Takeda-ism values across all activities
• Ensure timely completion of assigned training, SOP reading, and assessments
• Perform additional duties as assigned by management

Education & Qualifications

• Bachelor’s degree in a Life Science discipline (e.g., Chemistry, Biology) required
• Minimum 6 years of practical experience in a GMP QC environment

Experience Required

• Proven experience in Small Molecule Analytical Method Transfers, including HPLC/GC
• Strong technical writing skills and experience authoring SOPs, protocols, and reports
• Experience supporting regulatory audits (e.g., HPRA, FDA)
• Familiarity with both Drug Product and API testing (e.g., dissolution, assay, wet chemistry)
• Experience using Empower software (preferred)

Skills & Competencies

• Strong project and time management skills
• Highly self-motivated with the ability to work independently
• Effective communication and cross-functional collaboration skills

What you can look forward to with us:

• Competitive Salary: Including performance-based bonuses.
• Retirement Plan: Employer contributions to your retirement plan.
• Comprehensive Insurance: Employer-funded private medical insurance with dependants’ cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.
• Electric Charging Points: Available at parking locations.
• Employee Assistance Program: Support for personal and professional challenges.
• Wellbeing and Engagement: Dedicated teams to support your wellbeing.
• Family-Friendly Policies: Supportive policies for a balanced work-life.
• Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.
• Development Opportunities: Coaching, mentoring, educational programs, and formal training.
• Subsidized Canteen: Enjoy meals at a reduced cost.
• Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

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