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The BBI Group aim to create a world where everyone has the opportunity for a better quality of life. We have served the global diagnostics industry for over 50 years and due to our continued growth, we are seeking a Quality Assurance Technician to join our team. This is a permanent, full time position based at our facility in Maine.

Role Overview

As a Quality Assurance Technician, you would be responsible for generating product labels; maintaining all production batch records, including scanning of all batch records. You would generate and implement standard operating procedures for production and support all activities of the Quality Assurance Department.

Role Requirements

Key responsibilities will include but are not limited to:

• Generate product labels.
• Maintain all batch records, including scanning of batch records.
• Generate and implement Standard Operating Procedures.
• Maintain the training program.
• Maintain the control of all documentation.
• Support all activities of the Quality Assurance Department.
• Generate and implement all Standard Operating Procedures.
• Interface with all customers regarding regulatory affairs and audits.
• Interface with the FDA, USDA and NIH regarding our application for compliance with each of these three federal bodies.
• Implement and monitor all regulations from local agencies.
• Establish all specifications for in-coming raw materials and out-going finished products.
• Oversee the release criteria for all new products and services.
• Maintain all production batch records.

The ideal candidate for this position will hold a minimum of a High School Diploma. Experience with document control and or ISO13485 would be advantageous. We are seeking an individual who has excellent planning and organisational skills with a high level of attention to detail.

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.

About The BBI Group

BBI Solutions has been serving the global diagnostics industry for over 50 years, and is the world?s largest independent producer of immuno-diagnostics reagents. We develop and manufacture critical components for the diagnostic industry, but also apply our expertise by delivering solutions that bring critical components together in the development and manufacture of point of care and conventional tests. Furthermore, our Novarum Mobile Diagnostic Platform complements across the diagnostics workflow to interpret and share assay results. This makes BBI unique among IVD suppliers.

Our range of immuno-diagnostics reagents includes human antigens, antibodies, enzymes and serum & plasma products. With manufacturing sites spanning four continents, we produce world-renowned labels for lateral flow, ELISA assay and biosensors, including our high-quality gold nanoparticles and glucose oxidase. The acquisition of German-based DIARECT AG in June 2020 established BBI as the leading provider of antigens in the autoimmune and tick-borne IVD markets.

BBI Solutions is part of the BBI Group.

Benefits

Here at BBI, we are committed to promoting and protecting the physical and mental health and well-being of all our employees. They play a pivotal role in improving the quality of people?s lives and are focused on delivering exceptional products and technologies. 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.

Recognising that our people are our strength, we offer an attractive benefits package to our employees:

• Medical & Dental Insurance Cover
• Life & Short-Term Disability Insurance
• Vision & Long-Term Disability Insurance
• 401k Retirement Savings Plan
• Global Employee Wellbeing Programme
• Reward and Recognition Programme
• Commitment to Career Development
• Generous Annual Leave Package
• Refer A Friend Scheme
• 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.

Application Process

If this role sounds like it?s for you, click ?apply? today. Once we?ve received your application, a member of our recruitment team will be in touch to arrange a call. On this call, we?ll be able to tell you a lot more about working here at The BBI Group, how ?a day in the life? of this position looks and discuss the next stages of the recruitment process.

Stay in Touch

To stay up to date with The BBI Group?s global activities, take a look at our Facebook, Twitter and LinkedIn pages. Click follow to receive the most up to date job and event information.

Key Words

Quality, Quality Assurance, Antibodies, Antibody, Scientist, Science, Medical, MedicalDevice, LateralFlow, BBIGroup, BBISolutions, Laboratory, LabWork, CleanRoom, Manufacture, Manufacturing

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Referral program
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Work Location: One location