Job Description Quality Control / Microbiologist
The purpose of the position is to provide technical expertise in the area of pharmaceutical Quality Control / Microbiology. The position functions in a cooperative effort to provide quality control and assurance to the operational departments involved in the manufacture of pharmaceutical products. This position will also participate in communicating validation activities during audits by customers, and regulatory authorities. The position requires executing roles and responsibilities with minimal supervision, as well as the ability to identify, analyze, and resolve the unique situations presented in the commissioning, and qualification of a sterile injectable facility.
The Quality Control / Microbiologist position also is responsible for the oversight of activities to ensure the facility, equipment, and utilities are qualified for usage as per design. The expectation of the individual in this position is that they will support setting up and maintaining the micro lab and analytical equipment for the corresponding validation programs by writing, executing, or providing oversight for detailed protocols, and reports. They will also document the validation activities of the facility systems, environmental monitoring, and utilities in compliance with the appropriate regulatory agency validation requirements.
Duties and Responsibilities
Conduct routine testing of raw materials, packaging materials, finished products and environmental samples (viable and non-viable air and surface) using approved methods and various instrumentation, (e.g. TOC, HPLC, FTIR, Liquid Partial, Endotoxin, Autoclave, etc.) while adhering to cGMP and established policy.
Generate valid data at expected levels of productivity while adhering to cGMP.
Interpret validity of own test data and generate accurate results.
Advise immediate supervisor or designee of all important aspects of testing including deviations.
Evaluate data generated by others in the analytical group.
Accurately document data and review official laboratory documents (e.g., SOP's, Technical reports, Methods, and specifications).
Maintain and troubleshoot laboratory instruments.
Maintain appropriate documentation of training activities.
Skills And Requirements
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned:
Conduct routine environmental and systems monitoring of manufacturing and laboratory areas.
Conduct general laboratory experimentation in compliance with the instructions provided in approved SOPs to determine appropriate actions.
Follow policies and assist in the development of new procedures and/or documentation.
Maintain records of experiments performed and results obtained, including related calculations.
Assist in the interpretation of data as required, and conduct accurate and precise experimentation, and complete documentation of results.
Education
Bachelor of Science degree in Microbiology / Chemistry or other life science from an accredited college or university or equivalent experience.
Experience
Min 5 to 8 years of total professional experience in a pharmaceutical facility in the microbiology Quality Control department
Competencies
Functional
o Knowledge of sterile formulation engineering
o Knowledge of USFDA, cGMP, GLP, ISPE, ISO
o Project management experience
o Planning and execution of qualification activities
Behavioral
o Results oriented
o Innovative thinker
o Time management skills
o Problem-solving skills, and a high level of self-motivation
o Strong interpersonal skills
o Strong written and verbal communication