Quality Assurance Specialist

Posted 11 January 2022
£25000.00 - £29000.00 per annum
Job type Permanent
DisciplineLife Sciences

Job description

Quality Assurance Officer
£25,000 - £29,000

Kelly Scientific, working on behalf of our global Biotech partner are looking to speak with talented individuals experienced of working within Quality Assurance from the Life Sciences industry.
Our client, a rapidly growing and expanding specialist within human cell culture, develop new and innovative products and solutions for drug discovery and toxicology.

Reporting to the Quality Manager, the QA will be responsible for maintaining the ISO9001 quality system.

A detail orientated and passionate individual, you will be accountable performing day-to-day tasks relating to the Quality Assurance function. These will include continual improvement of the quality systems, processes and procedures with a focus on conducting quality assurance reviews of validation documentation and providing quality oversight to Manufacturing and QC teams.
Reporting to the Quality Manager, with a proven track record as a successful Quality Assurance role within a Life Sciences environment, you will be responsible for ensuring products meet the established standards of quality including reliability, usability and performance required for commercial markets.

Key Responsibilities
· Planning, developing and implementing effective quality assurance policies and procedures
· Creating, reviewing and maintaining supplier approval records as well as generated SCARS
· Be responsible for QA approval of documentation and preparation of Certificates of Analysis with associated QA documentation
· Undertake continuous improvement initiatives through internal audits and supporting associated companywide activities
· Collecting and working on feedback and complaints provided from customers
· Conducting non-conformance and CAPA procedures to determine root cause and implementation of necessary corrective and preventive actions
· Ensuring activities and processes across the site meet regulatory standards
· Work with the Quality Manager and scientists to design and development of Standard Operating Procedures for on-going product and process development
· Support the Quality Manager in ensuring all QA activities meet company, product and regulatory requirements
· Provide support to relevant stakeholder groups to ensure all quality systems processes and procedures meet New Product Introduction, Product and Process Change
· Maintain ISO9001 quality management systems and assist the Quality Manager in delivering the QMS infrastructure to achieve ISO17025 certification
· Travel to and provide support for Cambridge site leadership and Quality Assurance team as required

The successful candidate will be
· A highly analytical and passionate Quality Assurance Officer, proven experience working within a dynamic commercial laboratory environment
· Working knowledge and ability to apply ISO 9001 regulations
· A natural problem solver that can identify short term mitigation and propose options for longer term resolution
· Experience conducting quality reviews of validation documentation
· Strong attention to detail
· Demonstrable success in developing and managing Standard Operating Procedure
· Excellent interpersonal skills and ability to work with groups

On offer, is a competitive salary, company wide performance related bonus, 8% pension contributions.

If you are interested in this position, please apply or contact the Kelly Scientific team for more information.

Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.

As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.