We are looking to appoint a QA Documentation Specialist who will join the QA Department on a full-time basis.
As part of a dedicated team, you will follow policies and procedures for updating and maintaining records and data in quality management system. You will work with originators from all departments to translate their documentation into the appropriate and acceptable formats. Coordinates and assures that documentation is written, edited, reviewed and approved in a timely manner to meet established deadlines.
To be a successful in this role, you will prepare documentation according to GMP requirements using appropriate validated software, circulate documentation for review/approval and training using the online documentation system. You will provide first line support for users of the online documentation system. Preparation of documentation for batch folders, issue-controlled documents according to GMP requirements. You will need to archive/retrieve quality records from the onsite storage area according to GMP requirements plus the destruction of archived quality records, as per company policy and according to GMP requirements. Author relevant documents within the department and assist in the release of information and data in response to requests.
The successful candidate will have education and / or experience in some, or all, of the following areas:
Working knowledge of Microsoft Office including Word, Visio, Excel and Access (extensive knowledge of word e.g. formatting, tables, images etc.)
About us:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.
Equal Opportunities
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics, or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions. Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the Company’s internal recruiting team.