- Posted 26 April 2022
- DisciplineLife Science
- Contact NameBinxa Auta
Orion Group have an exciting opportunity with Our Multinational Medical Device Client located in Hull, UK. We are sourcing a QA Microbiology Analyst on an initial 6-month contract role.
The role holder will carry out quality activities to ensure efficient and effective processes for laboratory testing, trending of data, sterilisation and project work, resolution of actions arising and compliance with site Quality Systems.
- Provide microbiological testing (water testing, environmental measurement and potentially bioburden) and associated support (media prep, consumable detrash etc).
- Effectively collate and accurately review records which comprise the microbiological information supporting environmental / bioburden control and assurance of sterility (records open to scrutiny by regulatory bodies where failure to comply can have serious implications for the business).
- Report results on time in full in a busy laboratory, support projects and manufacturing.
- Develop an acceptable standard of microbiological expertise in the team such that results are reliably generated at the first attempt
- Take appropriate action to out of specification results reported within the microbiology laboratory as per set procedure.
- Abide at all times to company policies & procedures, and the governing standards & regulations, including (but not limited to):
Applicable standards as defined in the Quality Manual (including but not limited to)
o ISO 9001
o ISO 14001
o ISO 13485
* Applicable regulations as defined in the Quality Manual (including but not limited to)
o EU Medical Device Directive / Regulation
o Regulations issued by the 5 MDSAP Jurisdictions
o UK Human Medicines & Medical Device Regulations
o cGMP, cGDP (including 2013/C 343/01), cGLP as applicable
- A degree in a biological science or at least three years' experience as a laboratory technician.
- Knowledge of GMP and of the microbiological control of environmental and bioburden
- Quality lab background desirable
- Monitoring programmes to support sterile device / pharmaceutical products manufacture.
- Basic knowledge of gamma and ETO sterilisation
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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.