QC Operations Scientist

WuXi Biologics; Dundalk; On-site; EUR 55,000 - 70,000; Full time

Job summary

WuXi Biologics in Ireland is seeking a QC Operations Scientist for a 12-month fixed-term contract to join a fast-paced quality team dedicated to upholding cGMP and regulatory standards. This role covers QC instruments, sample management and computer systems while supporting ongoing projects.

You will contribute to laboratory startup and routine operations, qualification and validation activities, and the development of training materials for QC personnel, aligning with WuXi Biologics' PROUD

Qualifications

• Bachelor's degree or higher in a science/quality discipline.
• Experience with routine and non-routine testing and sampling methods.
• Familiarity with pharmacopeia testing methods and requirements.
• Knowledge of FDA/EMA regulatory requirements and GMP guidelines is desirable.

Responsibilities

• Ensure startup and routine QC operations are performed safely.
• Support QC lab setup, equipment installation and qualification.
• Develop and maintain quality systems to ensure cGMP compliance.
• Assist in audits, training material development and QA investigations.

Skills

Communication

Troubleshooting

Teamwork

Problem solving

Education

University degree in related science/quality

Job description

QC Operations Scientist - 12mth Fixed Term Contract

The QC Operations Scientist will be responsible for carrying out tasks and supporting projects relating to QC instruments/equipment, computer systems, sample management, and general QC-compliance functions while ensuring the highest standards of Good Laboratory Practices, regulatory requirements and quality within the business is adhered to. As part of the project the role will evolve based on project timelines.

Department Description

As QC Operations Scientist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the QC Operations Team Lead. This role will be offered as a 12month Fixed Term Contract.

Essential Duties and Responsibilities

• Ensure the tasks associated with the startup and routine operations of a QC Operations laboratory are carried out in a safe manner.
• Support QC Operations lab set-up, including laboratory design, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
• Support facility qualification, process validation, etc.
• Develop and maintain quality systems within the QC Operations Laboratory to ensure compliance to cGLP.
• Aiding in the identification and development of Contract Test laboratories and strategies.
• Development of training material for the QC Operations Laboratory personnel.
• Support and lead QC test method validation and development of routine testing strategies when required.
• Perform additional duties at the request of the direct manager.
• Routine monitoring of laboratory KPI’s, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
• Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.
• Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
• Support Risk Assessments for projects and business innovation initiatives from a QC Operational perspective.
• Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations.
• Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
• Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits. Participate in relevant internal and external QC related audits.
• Ability to work in a team environment and independently as required.
• Train other QC team members and Manufacturing personnel in laboratory methods and procedures when required.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
• Thorough understanding of current Good Manufacturing Practices.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Operations Senior Scientist.
• Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Person Specification

Qualifications

• University degree in related science/quality discipline required.
• Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Familiarity with Pharmacopeia testing methods and requirements.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable.
• Experience with regulatory/customer audits is desirable.

Knowledge/Experience:

• Experience in a large-scale Biopharmaceutical/pharmaceutical facility.
• Experience with facility start-up projects (brown field or green field) is desirable.
• Experience in Training of personnel.
• Previous experience in a Quality Control/GMP environment is required.
• Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.
• Excellent communication, interpersonal and presentation skills.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
• Collaborative and inclusive approach to work and your colleagues.
• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
• Engage cross functionally in conjunction with a site-based team.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! WuXi Biologics is an equal opportunities employer.