QC Microbiologist

Responsibilities:

• Actively contribute to a collaborative team environment, taking on leadership and support roles in various initiatives and projects. Opportunities for skill development and cross-functional training will be available.

• Manage and prioritize tasks for yourself and team members, ensuring alignment with project goals and timelines. Review and validate work outputs to ensure compliance with internal procedures and quality standards.

• Collaborate with internal stakeholders to resolve issues related to quality control, addressing non-conformance events at all stages of production, including materials, in-process testing, and finished goods.

• Assist in the setup and operationalization of a new microbiological testing laboratory, supporting leadership and cross-functional teams in the process.

• Perform routine sampling across a variety of materials, including raw materials, in-process samples, finished products, and stability samples, ensuring consistent adherence to quality control protocols.

• Conduct standard microbiological testing on a range of samples, ensuring that all tests align with regulatory requirements, established procedures, and internal quality standards.

• Execute routine laboratory procedures, such as weighing, preparing glassware, equipment calibration, and reviewing laboratory test results to ensure accuracy and compliance with standard operating procedures (SOPs).

• Conduct preventive maintenance on laboratory instrumentation in accordance with established SOPs or support vendors in accessing equipment when specialized maintenance is required.

• Troubleshoot laboratory procedures, test methods, and equipment malfunctions, participating in investigations related to deviations or out-of-specification (OOS) results.

Qualifications:

• A Bachelor’s degree in a scientific discipline (e.g., Microbiology, Biology or Biochemistry)

• Strong analytical skills, attention to detail, and the ability to document results thoroughly and accurately.

• Excellent communication skills, both written and verbal, with the ability to collaborate effectively within a team and across departments.

• Ability to work in a regulated environment and adhere to strict quality and compliance standards.

• Proficiency in using laboratory data management systems (e.g., LIMS) and other data analysis tools (e.g., JMP, Minitab) for reporting and documentation purposes.

• Experience with microbiological testing methods for endotoxins, sterility, and bioburden.

• Familiarity with environmental monitoring practices and standards.

• Experience working in controlled environments for aseptic processing or sterile manufacturing.