Project Coordinator in Oberdorf
Project Coordinator - Oberdorf
Jocelyn Blackham is recruiting for a Project Coordinator to join a company in the Medical Device industry at their site based in Oberdorf on a permanent contract.
The main purpose of the role will be to:
- Coordinate test samples for evaluation at internal and external contract laboratories, including calculation of sample numbers required for testing, ensuring proper labelling of samples, and clear communication with research teams providing samples.
- Request quotes from CROs.
- Receive and distribute samples as per GLP and departmental SOPs, maintaining accurate and contemporary tracking records.
- Track study progress to ensure timely delivery of data and reports.
- Ensure appropriate documentation is established & maintained in study files to ensure study integrity and timely submission to document archives; verify information in protocols and reports.
- Ensure that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices and Radiological Health) and GLP (Good Laboratory Practice).
Further responsibilities will include:
- Maintain proper records of project request and testing to allow for preparation of metrics and reporting to management.
- Report to management on department activities, non-conformances, and problems related to sample preparation, CRO delays, and overall project flow for planning purposes.
- Support on-site and off-site Regulatory Authority audits to support product evaluation and testing as required (e.g. Test Article Control Room audits, GLP Archives audits).
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A Bachelor's degree in biology, chemistry, microbiology, biomedical engineering or a related scientific field is required.
- Previous experience in industrial research, academic research, or product development experience in a highly regulated healthcare environment is required.
- Experience working with contract research organizations is preferred.
- Familiarity with medical device product development is preferred.
- Fluent English and German skills are required.
This is an excellent opportunity to join a global medical device company.
For more information or to apply for this position, please contact Project Coordinator on 0041 (0) 41 727 6793 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS44500 in all correspondence.