Senior Microbiologist

1 week ago

Allentown, Pennsylvania, United States Joulé Full time

Job Title:
Senior Microbiologist - Quality Assurance

Location:
Allentown, PA

Type:
Full Time, Salaried with benefits

Schedule:
M-F

A leading organization in the medical device sector is in search of an experienced Microbiologist to enhance their team.

Key Responsibilities:

Oversee, coordinate, and manage the overall operations of the Microbiological Laboratory, ensuring compliance with both internal and external standards while maintaining cost-effectiveness.

Take direct responsibility for supervising testing operations at all times, including Sterility Testing, Bacterial Endotoxin Testing, Microbiological Identification, and managing laboratory results.

Ensure that all necessary microbiological tests are conducted in accordance with established specifications, methods, and protocols, guaranteeing timely release of pharmaceutical products and medical devices.

Accountable for the preparation and regular updates of GMP/ISO procedures relevant to the area of responsibility.

Collaborate on projects and task forces with production teams as needed.

Conduct trend analysis and compile data on production process deviations when necessary.

Engage in both internal and external audits.

Participate in the Global Microbiology Task Team as required.

Responsible for the microbiological release of medical devices and pharmaceutical products, as well as incoming materials.

Support microbiological tasks related to process validation.

Mentor and develop training standards for responsible personnel.


Qualifications:
A Bachelor's degree is required; a Master's degree is preferred.
Demonstrated leadership skills and experience in educational training will be considered.
Previous supervisory experience is essential.
cGMP experience and aseptic processing training are required.

#M3

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