Bio-Techne Jobs

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Bio-Techne QA Coordinator (12 Month Fixed Term Contract) in Abingdon, Minnesota

By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.

Position Summary:

This role is a fixed term contract position for maternity cover up to 12 months but may be less dependent on the maternity leave.

Bio-Techne is a world-leading developer and manufacturer of high-quality life science reagents and is seeking a QA Coordinator to join their growing QA department.

The successful candidate, reporting to the Senior Quality and Compliance Manager EMEA, will be responsible for ensuring compliance to the ISO 9001 and ISO 14001 integrated management system (IMS) for the EMEA Business Unit of Bio-Techne. They will be responsible for key processes within the IMS as detailed in the section below. They will also be responsible for responding to customer quality queries, customer quality questionnaires and setting up Quality Agreements with customers as required. The operations of this business unit cover Sales, Marketing, Purchasing, Order Processing, Warehousing, Distribution and Customer Service of Cell Biology Research Products and Instruments.

Key Responsibilities:

• Responsible for responding to customer quality requests, completion of customer quality questionnaires and setting up Quality Agreements with customers.

• Review any CAPA and non-conformances raised in the IMS and working with owners to ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.

• Responsible for the internal audit schedule for the EMEA ISO 9001 and ISO 14001 integrated management system. This includes issuance of the audit schedules, conducting audits, working with support auditors from other departments, reporting any findings and tracking completion of actions and trending of findings.

• Preparation and assisting the Senior Quality and Compliance Manager EMEA with the hosting of ISO 9001 and ISO 14001 recertification and surveillance audits.

• Ensuring documentation in the ISO 9001 and ISO 14001 Integrated Management System is current and controlled.

• Responsible for the review and approval of process changes to the IMS to ensure all changes to assessed and implemented correctly.

• Responsible for the Approved Supplier List and approval of new suppliers.

• Supporting environmental compliance operations as required.

• Organise and participate in internal ISO 9001 and ISO 14001 related training sessions.

• Any other task or project as required by the business.

Qualifications

Education and Experience

Essential:

• BSc/BA degree educated

• Experience of working within a Quality Assurance or Quality Systems function within an ISO 9001 and/or ISO 14001 Management System, or similar

• Experienced internal auditor for ISO 9001 and/or ISO 14001, or similar

• Experience of investigating/reviewing CAPA and an understanding of root cause analysis tools

• Experienced in QA / QMS activities such as documentation control and change control processes

• Experience of responding to customer quality related queries

Desirable

• IRCA certified internal auditor for ISO 9001 and/or ISO 14001

• Previous experience of responding to customer requests for quality questionnaires and setting up Quality Agreements with customers

• Experience of participating in recertification / surveillance audits for ISO 9001 or ISO 14001

• Previous involvement in supplier quality processes

• Experience of conducting QA/QMS training

Personal Qualities and attributes:

• Excellent team working skills

• Ability to critically review documentation

• Methodical, process orientated and highly organised

• Excellent attention to detail

• Excellent time management skills

• Excellent verbal and written communication skills in English

• Problem solving ability

• Flexible with a can-do attitude

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.

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