QC Operations Support Associate

.

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

- This position is onsite in Tralee

Working Hours

- This position may require shift work

Purpose and Scope

The QC Operations Support Associate provides essential GMP QC support in a highly regulated Annex 1 aseptic manufacturing facility. The role ensures compliant execution of line clearance, environmental monitoring, water and clean steam sampling, and batch record review supporting sterile medicinal product.
This position is critical to maintaining the facility’s Contamination Control Strategy (CCS), ensuring classified areas remain in a validated state and that all activities meet the expectations outlined in EU GMP Annex 1, EU GMP Vol. 4, and internal procedures.

The work schedule is subject to change to support business operations

Role and Responsibilities

- Carry out all tasks in accordance with Good Manufacturing Practices.

- Compliance with all safety requirements associated with working in the facility.

- Line Clearance & Aseptic Readiness

- Verification that any interventions are conducted in a manner that complies with the site Contamination Control Strategy

- Environmental Monitoring; execution of viable and non-viable monitoring in Grade C & D areas.

- Support EM investigations, root cause analysis and CAPA.

- Perform Aseptic sampling of Purified Water, Water for Injection and Clean Steam following validated procedures.

- Conduct real time and retrospective Batch Record reviews. Conduct review of all process related logbooks for completion and ALCOA+ principles.

- Compliance, Data Integrity & Documentation

- Audit & Inspection Readiness

- Author and update processes to ensure a compliant and lean operation.

- Own incident reports, non-conformances, change controls, CAPAs and OOS investigations.

- Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.

Essential Qualifications

- B.Sc. degree in Microbiology, Biotechnology or similar field

Preferred Qualifications

- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.

Benefits

Careers | Astellas

Why Astellas

- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Integrity, Innovation and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.

Our Organisational Values and Behaviours

Integrity Innovation Impact One Astellas Accountability Courage Sense of Urgency Outcome Focus
## Skills and Capabilities

Organizational Focus
## .

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

#LI-Tralee
#LI-onsite
#LI-LL1