As part of a dedicated team, you will perform inspections, check testing and sampling procedures for product manufacturing processes. You will carry out packaging line, manufacturing inspections and sampling and testing of incoming components and raw materials to ensure that company standards are met. You may assist with validating or troubleshooting testing methods, including assays.
To be successful in this role, you will perform an array of microbiological environmental sampling, such as active air, passive air, surface bioburden and non-viable particulate monitoring. You will also perform microbiological sampling and testing of site utilities such as purified water, compressed gases and pure steam, along with microbial testing, including but not limited to bioburden assessment using filtration; detection of endotoxin; basic identification of microorganisms; media growth promotion, etc. You will work in a variety of business units, such as the QC Microbiology laboratory, production environments, and GMP cleanrooms. You will keep accurate and detailed records of all laboratory work in accordance with company procedures; completion of Good Manufacturing Practices (GMP) testing paperwork to a high specification in line with ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) expectations. You will ensure laboratory media, chemicals and consumables are stocked to prevent testing delays. You will ensure equipment, instruments, and facilities within the laboratory are calibrated, and kept serviceable. You will ensure all QC working practices are in compliance with the requirements of EudraLex v. 4, where required.
The successful candidate will have education and / or experience in some, or all, of the following areas:
* 8 years relevant work experience or associate degree with 3-5 years relevant work experience or Bachelor’s degree with 1-2 years relevant experience preferred
* Proficient in aseptic technique and experience of working in a QC Microbiology laboratory
* A degree of familiarity of sampling within production and cleanrooms
* Diligent and with a meticulous approach to all tasks, with a keen eye for detail
* Good IT skills e.g. Microsoft Office (Word, Excel and Outlook)
* Strong analytical and problem solving ability
* Good planning, organizational, and time management skills
* Experience in Kaizen/Lean/Sigma an asset
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, color, 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.
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