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
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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