Quality Assurance Specialist

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 Specialist to join our team. This is a permanent, full time position based at our facility in Maine.
Role Overview
The Quality Assurance Specialist would be responsible for implementation and execution of all Quality elements at the Portland, Maine site.    They are responsible for the implementation of global and site quality procedures, work instructions, and processes ensuring BBI's Quality vision and plans are deployed.
The Quality Assurance Specialist independently contributes to the Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment calibration and maintenance program, product and process planning, quality audits, validation, and document control. 
The Quality Assurance Specialist reviews production batch records for accuracy and completeness and supports record retention including scanning of all batch records.
The Quality Assurance Specialist reports all deviations and assures that these have been addresses and resolved prior to issuing approval and release of the production.  They maintain the training program, participate in cross-functional teams and plan for continuous improvements.
Role Requirements
Key responsibilities will include but are not limited to:
Role Specific:

• Responsible for maintaining the site and Global Quality System QMS in accordance with ISO 13485.
• Work unsupervised on multiple QMS projects striving to achieve target dates with regular communication on progress.
• Identify and challenge existing practices to become more effective for the business and customers.
• Support the maintenance of the eQMS.
• Accountable for ensuing all quality and regulatory compliance needs of customers are incorporated into the site QMS.
• Support the audit hosting process (customer, certification body etc.).
• Support/deliver site inductions from the QA/RA function.
• Prepare/execute internal Quality Management System audits.
• Maintain positive relationships with site functions to resolve customer issues.
• Ensure customer requests, general queries, requests for documentation and completion of questionnaires are completed in a timely manner for the scope of the department.

Portland, Maine, USA:

• Generate and implement all Standard Operating Procedures.
• Interface with all customers regarding regulatory affairs and audits.
• Interface with the USDA and NIH regarding our application for compliance with these 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.

Quality Specific Goals:

• Aware of and comply with the BBI Quality Policy, Quality Goals, and applicable laws and regulations as they apply to this position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report and quality or compliance concerns and take immediate corrective action as required.
• Meet BBI QMS procedure deployment plan dates.
• Assure BBI sites are properly prepared for external and internal compliance inspections finding no systemic or warning letter findings related Supplier quality.
• Assure specific goals are established and met for global QMS development, deployment, certification, and maintenance.

General:

• To always work in accordance with company standards and regulatory guidelines
• To actively meet individual, team and company aims and objectives.
• To display company core values at all times.
• To behave in a positive and professional manner.
• To demonstrate clear and concise written and verbal communication skills.
• To be highly self-motivated and organized.
• To demonstrate excellent customer care skills.
• To provide suggestions that will contribute to the development of the Company.
• To work as part of the team and help foster good working relationships.
• To actively keep updated with the company's products and services.
• To keep up to date with relevant industry developments.
• To adhere to the Company Health and Safety policy
• To report any unsafe conditions, equipment or practices immediately to the appropriate manager.
• To develop yourself where appropriate by attending courses, meetings, training events, workshops and seminars, in order to not only develop yourself but also the company.
• To follow all company policies and procedures.
• To conduct any other duties as requested by your Manager.

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:
Competitive Salary with Yearly Salary Reviews
Medical & Dental Insurance Cover
Life & Short-Term Disability Insurance
Vision & Long-Term Disability Insurance
401k Retirement Savings Plan
Private Health Care Scheme
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
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