Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Newport

Description

The Company

The BBI Group offers a portfolio of products and services to the diagnostic, healthcare, research, defence and food industries globally.

Our mission is to deliver exceptional products and technologies that people rely on to enjoy a better quality of life. Through innovation, partnership, effective delivery and the collaboration of our people, we constantly strive to help set industry standards, engender trust and build our reputation for excellence.

As a business, we are currently progressing through an exciting period of growth and as part of our exciting expansion plans, we currently have an opportunity to hire a QC Scientist for our BBI Solutions division. The role will be based at our Global Headquarters in Crumlin.

BBI Solutions has served the global diagnostics industry for over 50 years, as a leading developer and manufacturer of raw materials and finished test platforms for the in-vitro diagnostics market.

Benefits

The salary offered for this role is competitive and makes up part of BBI’s attractive benefits package, which includes:


- 5% contributory pension scheme
- Life Assurance
- Private health care scheme
- Generous annual leave package totalling 32 days (inclusive of bank holidays)
- Participation in the childcare voucher and cycle to work schemes

The Role

As the QC Scientist, you will perform in-process and final testing on the BBI Diagnostic product range, including rapid tests, liquid conjugates and gold colloid, ensuring that all QC activities comply with our quality standards (ISO 9001:2008, ISO 13485:2003 and the and the ANVISA RDC 16/13 regulations)

Duties and responsibilities will include, but not be limited to the following:


- Carry out in-process and final tests to support manufacturing and R&D activities
- Carry out testing of incoming raw materials and record results on Incoming Data Sheets (IDSs)
- Carry out cross-over studies on new QC controls; also, stability testing at scheduled intervals
- Carry out quality monitoring and trending of the Purified Water System and record results on monitoring form
- Manage QC inventory
- Carry out release of conjugates using the Sage 200 ERP system
- Initiate required changes to QC documents in accordance with change control procedures; similarly, in conjunction with R&D, for new procedures to support product development
- Record and investigate out of specification and out of trend results; also, deviations
- Manage stability trials and perform testing at scheduled intervals
- Ensure that all interactions with Customers by self are professional
- Lead or participate in quality improvement opportunities within QC
- Ensure all activities comply with Health and Safety legislation or BBI policies
- Ensure that all QC activities comply with relevant standards and regulations

The Person

As the QC Scientist, you will need to have a science-based degree, laboratory experience and ideally be familiar with cGMP/ ISO 13485 and working within a regulated environment. Previous exposure to QC processes will be desirable.

If you are an internal employee applying for this vacancy you and your manager are required to complete an internal transfer form. This needs to be completed in full and attached to your application along with your CV and cover letter.

  • erp
  • iso 9001