Microbiologist

Perform microbiological testing of raw materials, intermediates, API, drug product release and stability samples, as well as collection and testing of environmental monitoring samples, in accordance with cGMP requirements, company policies and procedures as directed by laboratory management.

Responsibilities:

Perform routine microbiological laboratory analysis, such as Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic methods), operate autoclave, and prepare media in accordance with Customer, schedule and cGMP requirements.

Perform environmental monitoring in support of aseptic manufacturing through the review of personnel training, data, exceptions, and EM trend reports. Obtain and maintain aseptic gowning qualification.

Read and understand test methodologies, study protocols, and Standard Operating Procedures in order to review or execute testing in compliance with necessary policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.

Qualifications:

Bachelor's degree in Microbiology or related scientific discipline with a minimum of 2-4 year, 4+ years preferred of experience in cGMP regulated environment is required.

Knowledge, Skills, and Abilities:

Rudimentary knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to aseptic manufacturing and analytical operations.

Rudimentary knowledge of USP, Pharm. Eur. and other compendial methods and procedures.

Rudimentary knowledge of microbiological practices, procedures, and common analyses, such as Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic Chromogenic methods), validation - Inhibition/Enhancement Sterility Test Method Validation (Bacteriostasis/Fungistasis), and Preservative Efficacy Testing.

Strong interpersonal skills. Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.

Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.

Ability to work effectively under pressure in a rapidly changing environment.

Ability to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.

Job Posted by ApplicantPro