QC Microbiology Analyst
The QC Microbiology Analyst will provide online QC oversight to Drug Substance/ Drug Product manufacturing operations This role is an 11 month contract with extended days shift which will include some weekends.
Responsibilities:
* Provide QC support to technology transfer and commercial manufacturing operations.
* Perform QC review of SOPs, risk assessments, change controls and other documentation, as applicable, associated with DS/DP manufacturing operations.
* Participate on microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, and process validation.
* Perform microbial testing and participate with atypical/OOS investigations, change controls, and CAPAs.
* Work with supervisors and other team members to review and monitor method performance.
* Author of technical documents including methods protocols, qualification / validation protocols and reports, SOPs, etc.
* Provide technical guidance, as well as evaluate / introduce new technologies in microbiology area.
* Assist Microbiology Lead to develop micro control strategies, quality enhancement, and operational efficiency improvement.
* Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
* Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
Required:
* BSc in Microbiology or related field years related industry experience.
* Demonstrated experience within highly regulated environment.
* ability to interpret technical documentation.
* knowledge of cGxP requirements and regulations.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to
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