ProClinical is partnering with a with a global biopharmaceutical company with a solid commercial portfolio of life-saving drugs to advertise a vacancy for a QC Microbiologist position. This is an exciting opportunity to join a company that boasts a growing pipeline of investigational drugs and unmatched patient access programs. The QC Microbiologist will join this organisation in their California-based office.
- Performing final product release testing, including those tests applicable for endotoxins and sterility.
- Performing raw material release testing including microbial limits and endotoxins.
- Performing testing, analysing, and submitting results so that commercial manufacturing activities are not impacted.
- Coordinating routine monitoring and validation activities.
- Ordering supplies and assigning expiry to incoming materials, tracking requisitions, and reconciling against incoming materials and invoices.
- Performing microbiological testing of raw material, in process, final product, validation-related, and critical utility samples.
- Performing bioburden testing of water and product.
- Performing Growth Promotional Testing for incoming media.
Skills and Requirements:
- A BS degree in Microbiology or equivalent.
- At least 1 years of relevant experience in the pharmaceutical industry.
- Working knowledge of GMPs, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry.
- A thorough understanding of Pharmacopoeia requirements and must be able to follow changes, implement changes, qualify methods.
- Understanding of USP/BP/JP and EP pharmacopoeias and the change process.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sherron Howard on + 267 435 8600 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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