QA Associate (Laboratory & QC)
ConvaTec is a leading developer and marketer of innovative medical technologies inspired by improving the lives of millions of patients around the world. With four key business units – Ostomy Care, Wound Therapeutics, Continence and Critical Care, and Infusion Devices – ConvaTec provides a broad array of products and customer solutions developed from rigorous science and borne from our collaboration with healthcare professionals and end-users. The company oversees more than 7,500 employees in over 90 countries serving consumers and their healthcare professionals.
Our plant in Rhymney, South Wales performs chemical conversion and fabric manufacturing processes to manufacture bulk intermediate product for our woundcare business and we are looking to appoint Quality Assurance Associate with a Laboratory and QC bias, to further develop our capability and to capitalise on the considerable strengths that lie behind a range of some of the world’s most prominent brand names in wound therapeutic care.
QA Associate (Laboratory & QC)
This role is a permanent position and the successful candidate should have an in depth knowledge and understanding of Quality and Laboratory management within the Medical Device or Pharmaceutical industry. Knowledge and experience of working to ISO 9001:2008, ISO 13485:2003, 21CFR: Part 820 is essential.
The candidate must have experience and a demonstrated ability of managing a busy physical and analytical test laboratory (including personnel, compliance and EHS requirements), reviewing test data, batch manufacturing data and approval of product. The candidate will have strong people management skills and proven experience of planning routine and non-routine testing to meet production output targets. In addition the role covers, environmental monitoring and GMP / personnel controls in the clean room environment, and water systems monitoring.
The role will deputise for quality assurance as required so experience of the management and implementation of core quality systems processes, such as Audit, NC, CAPA, Change Control and Validation would also be desirable.
Continual Improvement of systems, processes, practices and procedures will form an integral part of the role and candidates should have demonstrated ability to analyse data, technical problems, determine root causes and develop appropriate solutions. A six sigma green belt qualification or experience of the DMAIC process is desirable.
To be considered for the role you will need to have a degree or equivalent experience in a scientific discipline, ideally in a microbiological discipline, be an experienced laboratory supervisor, with strong people management and planning skills, have the relevant qualifications and/or experience to meet quality, environmental, health & safety compliance standards in the laboratory. Detailed knowledge of Quality Systems (such as ISO 13485, ISO 9001 and 21 CFR: Part 820) is desirable.
Benefits include an attractive salary package, including private healthcare, pension scheme, employee assistance programme and discretionary bonus scheme.
If this role sounds like your next career move, please send your CV, giving full details of your background and current salary to: Penny Clarke, Human Resources, ConvaTec Ltd, Units 1 & 2, Heads of the Valleys Industrial Estate, Rhymney, Gwent, NP22 5RL or by e-mail to penny.clarke@convatec.com. The closing date for applications is 6th March 2015