At a Glance
- Tasks: Join our QA team to ensure top-notch quality in life science products.
- Company: Bio-Techne is a leader in life science research tools, dedicated to quality and sustainability.
- Benefits: Enjoy a vibrant work culture, opportunities for growth, and a commitment to environmental responsibility.
- Why this job: Make a real impact on cutting-edge research while developing your skills in a dynamic environment.
- Qualifications: BSc/BA in a life science field with QA experience in a regulated environment required.
- Other info: Be part of a team that values quality, customer satisfaction, and continuous improvement.
The predicted salary is between 30000 - 42000 £ per year.
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: Bio-Techne is a world-leading developer and manufacturer of high quality life science reagents and is seeking a QA Officer to join their growing team in their QA department in Bristol. This successful candidate, reporting to the Quality Assurance Leader, will join a vibrant and dynamic Quality Assurance team covering Quality Assurance tasks relating to development and manufacture of GMP and RUO products. This is an exciting opportunity for a QA Officer to help maintain the current Quality Systems as well as get involved in continual improvement of these systems.
Key Responsibilities:
- Batch Record review and product: Review, approval and release of Batch Production Records and Quality Control testing data.
- Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
- CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
- Documentation Management: Writing, reviewing and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
- Change Control: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
- Training: Organise and participate in internal quality related training sessions.
- Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings and tracking completion of corrective actions.
- Supplier Quality: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials.
- Environmental Monitoring of the ISO 7 Cleanroom during weighing operations.
- Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
- Any other task as required by the business.
Qualifications Education and Experience Essential:
- BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
- Experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
- Experience of working within a cGMP environment.
- Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.
- Experienced in conducting final QA product release.
- Experienced in the critical review of CAPA / non-conformances / deviations / OOS.
- Experienced in documentation management systems and change control processes from a Quality Assurance perspective.
- Experienced internal auditor for ISO 9001, ISO 13485 or cGMP.
- Experienced in supplier quality processes.
- Experienced in investigation of customer complaints and customer technical support.
- Experience of conducting environmental monitoring of cleanrooms.
- Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products.
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.
QA Officer employer: Bio-Techne
Contact Detail:
Bio-Techne Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Officer
✨Tip Number 1
Familiarise yourself with the specific quality management systems and regulations mentioned in the job description, such as ISO 9001 and cGMP. This knowledge will not only help you understand the role better but also demonstrate your commitment to quality assurance during any discussions.
✨Tip Number 2
Network with current or former employees of Bio-Techne on platforms like LinkedIn. Engaging with them can provide you with insider insights about the company culture and expectations, which can be invaluable during interviews.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that relate to the key responsibilities listed in the job description, such as handling non-conformances or conducting internal audits. This will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and advancements in the life sciences and biotechnology sectors. Being knowledgeable about current developments can help you engage in meaningful conversations during interviews and show your passion for the field.
We think you need these skills to ace QA Officer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly in a cGMP environment. Emphasise your familiarity with ISO standards and any specific achievements related to quality systems.
Craft a Compelling Cover Letter: Write a cover letter that connects your background in life sciences with the responsibilities of the QA Officer role. Mention your problem-solving skills and how you can contribute to Bio-Techne's commitment to quality and environmental management.
Highlight Relevant Experience: In your application, focus on your experience with batch record reviews, CAPA processes, and documentation management. Provide specific examples of how you've successfully managed non-conformances or conducted internal audits.
Showcase Soft Skills: Don't forget to mention your personal qualities such as attention to detail, teamwork, and communication skills. These are crucial for a role that involves collaboration and training within the QA team.
How to prepare for a job interview at Bio-Techne
✨Know Your Quality Standards
Familiarise yourself with the key quality standards relevant to the role, such as ISO 9001 and ISO 13485. Be prepared to discuss how your previous experience aligns with these standards and how you can contribute to maintaining and improving them at Bio-Techne.
✨Demonstrate Problem-Solving Skills
Prepare examples of past experiences where you've successfully resolved non-conformances or CAPA issues. Highlight your methodical approach and ability to conduct root cause analysis, as this will showcase your problem-solving capabilities.
✨Showcase Teamwork and Communication
Since the role requires excellent team working skills, be ready to share instances where you've collaborated effectively with others. Emphasise your verbal and written communication skills, especially in relation to training sessions and internal audits.
✨Highlight Attention to Detail
Quality Assurance demands a keen eye for detail. Prepare to discuss how you ensure accuracy in documentation management and batch record reviews. Providing specific examples will help demonstrate your meticulous nature.