Job Description: Title: QC Microbiologist I

2nd Shift

Shift: Sunday - Wednesday (4 x 10 Hour Shifts) 2pm - 12am

Must have prior Micro experience, i.e environmental monitoring, endotoxin, and bioburden. Track wise experience also.
The QC Microbiology Associate II will be an integral member of the group ensuring operational readiness of the lab followed by performing Microbial testing to support GMP production. The key focuses will be to assist in the timely completion of in-process and release testing of clinical and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of viral vector cGMP compliant manufacturing and the transfer and validation of methods from clients. The incumbent will act as an analyst in the lab by assisting in routine testing, equipment setup, documentation, analytical method transfer / qualification, training, and keeping up cGMP compliance practice to support group needs.
What you will do...

Perform routine environmental monitoring and critical utility testing

Conduct routine microbiology assays including bioburden, endotoxin testing, growth promotion, plate enumeration, and microbial identification.

Recognize and report out-of-specification or unexpected results.

Clearly and accurately communicate the results of work by capturing of the testing/analysis and obtained results.

Record and report results of analysis in accordance with prescribed lab procedures and systems.

Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.

Contribute to writing of SOPs if needed.

Perform daily lab cleaning, preventative maintenance of equipment, ordering of supplies, and autoclaving of equipment.

Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.

Maintain the necessary compliance status required by company and facility standards.

Take part in process improvement initiatives & having a voice within the department.
How will you get here?

Education

Bachelors degree in science; preferably Microbiology or Biology
Experience

1 years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge, Skills, Abilities

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Strong attention to detail and ability to adhere to standard procedures.

Ability to function in a constantly evolving environment.

Must be fluent in English

Comments for Suppliers: Shift: Sunday - Wednesday (4 x 10 Hour Shifts) 2pm - 12am