Senior QC Scientist

• Private Health Care Scheme – including dental
• Global Employee Wellbeing Programme

Vacancy Name Senior QC Scientist Vacancy No

VN
993 Basis Permanent Duration Work Location Crumlin Job Details

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 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.

• Carry out incoming, in-process and final testing to support manufacturing and R&D activities using calibrated equipment and in accordance with QC Procedures.
• 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.

• 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 /ISO
  13485 requirements.
• Supervisory experience
• Project management experience
• Inventory management experience

• 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

For more than 70 years, we’ve been perfecting reagents, both native and recombinant, to help IVD and…