The microbiologist is to provide technical and managerial leadership over the microbiology lab while ensuring the finished product is safe, effective, and free of microbiological contamination.
The QC Microbiologist will be required to participate in industry events and organizations to remain current with new trends and requirements and provide microbiological technical leadership to Rockline’s laboratory working group.
Assists in the direction of the daily activities in the microbiology laboratory.
The microbiologist aids in performing all microbiological examinations on finished products, raw materials, stability, environmental and water samples in accordance with cGMP, Regulatory, and company procedures to meet all project and customer guidelines.
Understand the requirements and of an Environmental Monitoring Program for an OTC manufacturer and ensure the program is maintained.
Maintain the microbiology laboratory in a state of compliance and “audit readiness.”
Conduct the validation and transfer of microbiological methodologies as needed.
Work with external contacts to communicate with customers, suppliers, and contract labs for required micro specifications, testing methods, and presentation of data.
Education: Minimum BS in Microbiology or Biology plus 10-15 years experience working in a regulated cGMP laboratory environment.
Required Experience: Having had experience working in a microbiology lab for a chemical, API, OTC or other cosmetic manufacturer. Proficient in the microbiology testing as required by the FDA and USP for OTC, cosmetic and medical device manufacturers. Experienced is maintaining Environmental and Process Water monitoring systems. Experienced in identifying microbiological organisms and a strong working knowledge of their origin(s) and the potential risks associated with them.
Other Desired Training: Active member of professional microbiological organizations, ASQ Certification Training, Internal Auditing, Microbiological Equipment operation and maintenance, Various cGMP, Microbiological, Drug, Cosmetic, Regulatory, Quality Systems training.
Please send your resume to the following email address: firstname.lastname@example.org