This job has expired

Quality Control Microbiologist

Employer
Kelly Science Engineering Technology & Telecom
Location
Upper Montclair, NJ
Closing date
Feb 13, 2024
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.

Qualifications:
  • 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.

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

by Jobble

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