Senior Microbiologist

Senior Microbiologist- Pharmaceutical

Job Description:

We are seeking a meticulous and experienced QC Microbiologist to join a major pharmaceutical lab and aid in addressing deviation/investigation backlogs within the department.

Responsibilities:

• Conduct and meticulously document Microbiology and Environmental Monitoring investigations.
• Possess a robust understanding of Environmental Monitoring and Microbiology principles, alongside proven experience in technical writing.
• Perform comprehensive laboratory investigations encompassing OOS/OOT instances, technical protocol and report creation, as well as data review and trend analysis.
• Ensure all exception documentation thoroughly covers root cause, CAPA, and product impact.
• Oversee the thorough integration of root cause analysis, corrective action plans, preventative action strategies, and product impact assessment within investigations.
• Develop, implement, manage, and monitor the effectiveness of corrective action plans addressing exceptions.
• Support the GMP Compliance program within the Microbiology Laboratory, including management of training records, conducting internal and self-audits, overseeing compliance walk-throughs, SOPs and Methods management, and spearheading deviation reduction initiatives.

Qualifications:

• Bachelor’s or master’s degree in microbiology or a related field.
• Demonstrated expertise in Environmental Monitoring and Microbiology.
• Proven track record in technical writing, particularly within the context of laboratory investigations.
• Familiarity with GMP compliance and associated practices.
• Strong analytical skills, with the ability to conduct thorough investigations and data analysis.
• Excellent communication skills, both written and verbal.
• Ability to collaborate effectively within a team and manage multiple tasks efficiently.

Preferred Skills:

• Experience in managing and overseeing corrective action plans.
• Prior involvement in GMP compliance programs.
• Proficiency in developing and refining SOPs and Methods.