Job Title: Quality Control- Microbiology 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.
- Bachelors or masters 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.
- Experience in managing and overseeing corrective action plans.
- Prior involvement in GMP compliance programs.
- Proficiency in developing and refining SOPs and Methods.