Senior QC Scientist

BBI exists to help our customers create advances that improve health and save lives. We are seeking a Senior QC Scientist to join our team. This is a permanent, full-time position based at our site in Crumlin. Join our team: advancing health, together.

The Role

The QC Senior Scientist reports into a QC Team Leader and performs incoming, in-process and final quality control testing across the BBI product range. The QC Senior Scientist will ensure that all QC tests/activities under job description are carried out on time and in line with set specifications, customer requirements, global/site procedures, industry standards and regulations as required. The QC Senior Scientist supports the QC Scientists, leads improvement projects and deputises for QC Team Leader.

In this role your responsibilities will include:

• Carry out incoming, in-process and final testing to support manufacturing and R&D activities using calibrated equipment and in accordance with QCProcedures.
• Ensure all documentation is completed following ALCOA principles and with a "right first time" attitude
• Ensure that adequate and independent reviews of all QC records have been carried out by an authorised person prior to acceptance / release of product from QC
• Report any out of specification or out of trend results and any quality issues to QC Team Leader/Production Manager as soon as noticed.
• Use of root cause analysis and problem-solving tools to investigate causes of non-conformities, out of trend results and deviations. Support process improvements as required
• Schedule QC testing to ensure adherence to production and release schedule.
• Ensure QC team members are trained to conduct their assigned duties, manage team training records and matrices
• Support improvements within the QC department, using Continuous Improvement techniques such as lean, six sigma, Kaizen, Value Stream Mapping
• Champion 5S within the QC Laboratory
• Manage stability trials and perform testing at scheduled intervals, generate stability reports and maintain stability spreadsheets.
• Manage QC inventory.
• Support quality monitoring and trending of the Purified Water System and record results on monitoring form.
• Initiate required changes to QC documents in accordance with change control procedures.
• Support product development with new documentation generation.
• Act as key customer contact for specific products and represent QC at various meetings, including R&D project transfers.
• Participate in quality improvement opportunities within QC and support the quality improvement initiatives undertaken by other departments.
• Support QC Project Leader and QC Team Leaders with QC Project work.

You should apply if:

• Laboratory experience, report writing experience and be proficient in MS Word and Excel.
• Have relevant experience within the medical devices/pharmaceutical industry, ideally will be familiar with FDA/GMP /ISO13485 requirements.
• Supervisory experience
• Project management experience
• Inventory management experience

Why Choose BBI

We are committed to promoting and protecting the physical, financial, and emotional well-being of all our employees. With our employees focused on others, we're focused on them. That's why, at BBI, we're dedicated to providing our employees with access to global resources and site-specific benefits that support their health and wellbeing.

• Competitive Salary with Yearly Salary Reviews
• 5% Contributory Pension Scheme
• Life Assurance (4x Annual Salary)
• Private Health Care Scheme - including dental
• Global Employee Wellbeing Programme
• Reward and Recognition Programme
• Commitment to Career Development
• Generous Annual Leave Package
• Cycle to Work Scheme
• Refer A Friend Scheme
• Subsidised Canteen
• Free Onsite Parking
• Electrical Vehicle Lease Scheme
• Electrical Charging Points
• State of the Art Facilities - Certified Centres of Excellence

We're also focused on development, creating an environment that allows our employees to nurture their talent and empowers you to make a difference. This is achieved by providing our employees with access to learning opportunities to help achieve personal career goals.

About BBI

For more than 70 years, we've been perfecting reagents, both native and recombinant, to help IVD and life-science teams turn breakthrough ideas into reliable, life-saving advances.

Great products are only the start. From troubleshooting tricky performance issues and customising reagents to meeting new regulatory standards, our scientists work to clear obstacles and accelerate progress. That's why we continue to invest millions in new recombinant capabilities that help create diagnostics that improve health and save lives - in a more ethical and sustainable way than ever before.

Equal Opportunities

BBI are an equal opportunity employer and believe in fair treatment for all candidates. Qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

We ask that all applicants complete an equal opportunity monitoring form on a voluntary basis, with all submissions remaining anonymous. The information on the form will be used for monitoring purposes only and will not be used in any decision affecting you.

Please note that we reserve the right to close this advertisement at any time upon securing a suitable candidate.