POSITION SUMMARY

Bio-Techne is a world-leading developer and manufacturer of high quality life science reagents and is seeking a Senior QA Compliance Officer to join their growing team in their QA department in Bristol.
This successful candidate will join a vibrant and dynamic Quality Assurance team, working alongside the QA Compliance Team Leader, to coordinate and lead Quality Assurance tasks relating to ensuring compliance to the QMS and GMP regulations for products manufactured on the Bristol site. The Senior QA Compliance Officer will mentor and coach other QA Compliance Officers in QA Compliance requirements and business practices.
Reporting to the QA Compliance Team Leader the Senior QAC Officer will be a highly collaborative and proficient individual with excellent communication skills.
This is an exciting opportunity for a Senior QA Compliance Officer to help lead and maintain the current Quality Systems as well as get involved in continual improvement of these systems.

BY JOINING BIO-TECHNE, YOU’LL JOIN A COMPANY WITH A POWERFUL AND POSITIVE PURPOSE OF ENABLING CUTTING-EDGE RESEARCH IN LIFE SCIENCES AND CLINICAL DIAGNOSTICS. BIO-TECHNE, AND ALL OF ITS BRANDS, PROVIDES TOOLS FOR RESEARCHERS TO FURTHER TREAT AND PREVENT DISEASE WORLDWIDE.

Reports To: QA and regulatory Compliance Team Leader
Location: in Bristol, UK
Work type: Full-time (37.5 hours)

KEY RESPONSIBILITIES

• Leading activities that support ensuring site compliance with the ISO 9001:2015 QMS, EurdraLex Volume 4 Part II GMP regulations and other applicable legislation, by working closely with internal colleagues from all departments to ensure compliance requirements are recognised, understood and maintained.
• Assist with planning and scheduling activities in relation to Quality System internal audits across the Bristol site. Participate in the completion of internal audits in compliance with ISO 9001:2015 and applicable GMP regulations. Mentor and coach internal auditors.
• Oversight and administration of the Documentation Control system
• Lead Non-conformance system activities. Coordinate, approve and manage to completion Non-Conformances/Corrective Actions, working closely with colleagues from all areas to ensure items are effectively managed and closed in a timely manner. Ensure adequate root cause investigations are conducted. Identify NC trends and communicate these to quality and operational leaders.
• Lead Change Control and Deviation activities. Coordinate, assess, approve and manage to completion change controls and deviations, working closely with colleagues from all areas to ensure items are effectively managed and closed in a timely manner.
• Input into the Customer Product Complaint process for the Bio-Techne Bristol product portfolio.
• Gathering and analysing Quality Systems data, including assessment against KPIs to ensure the effectiveness of the Bristol QMS.
• Responsible for creating, maintaining and continually improving standard operating procedures (SOPs) to ensure compliance is met and maintained.
• Participate in customer and regulatory audits, including leading preparation activities, during the audit and any follow up activities.
• As required, participate in applicable meetings as the QA Compliance representative and serve as a contact for internal and external customer compliance matters for Bio-Techne Bristol products.
• Lead QA related training sessions for new starters and ongoing refresher training sessions for the business.
• Coordinate the QA Training Matrix to ensure it is up to date and training records have been completed as required.
• Regulatory Compliance activities related to Controlled Drugs.
• Provide cover for Supplier Quality and QA Batch Release Team, when required.
• Work closely with Quality, Manufacturing, Operations and Facilities teams to identify and support Quality System compliance and customer needs.
• Coach and mentor team members on QA Compliance and business requirements including best practices.
• Foster and support a culture of high performance, teamwork and exhibiting Bio-Techne’s EPIC values.
• Perform additional duties as assigned.