Senior Microbiologist
Description:
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.