We are starting up a new Microbiology Laboratory with CVS Health! This is a great opportunity to utilize your Microbiology and management experiences to create a new program from the ground up.
In this role, you will have ownership for the development of a brand new Microbiology laboratory that will support multiple facilities across the country producing aseptically-produced sterile compounds. Your team will monitor a national operation providing specialty home infusion care to over 40,000 patients per month! Read more details about this opportunity below:
As the Senior Microbiologist Advisor, you will demonstrate a high level of expertise in the practice of cGMP environmental monitoring in sterile manufacturing. In addition, you will assist with development of other SOPs related to clean room controls and processes, assuring cGMPs and company policies and procedures are followed and updated. You will be accountable for meeting functional area goals and objectives as they relate to departmental and company goals, while adhering to cGMP regulations, USP standards, and company policies.
* Oversee the viable and non-viable environmental monitoring throughout multiple facilities, according to established Policy and Procedures.
* Develop and manage all Processes and Policy and Procedures relevant to microbiology department. Including but not limited to: Data management, LIMS implementation, Trending Results, Equipment Setup and Validation, ID technology procurement, etc.
* Properly incubate and examine samples for microbial growth.Perform Gram stain as required and ID
* Complete all documentation properly according to cGMP requirements. Assess the limits compared to the results to determine if an excursion within the environment has occurred.
* Oversee data entry and trending of EM results into established data base. Create trending mechanism for all data and develop alert limits based upon historical data.
* Perform routing laboratory duties which may include environmental monitoring which may include media growth promotion and handling,autoclave operation, testing equipment maintenance, cleaning of laminar flow hoods, proper disposal of samples, etc.
* Assist with studies and investigations as needed. Complete additional sampling in response to investigative requirements.
* Maintain effectiveness of the Quality System components relevant to this position.
* Manage and oversee a team of direct reports.
* Create training material to train staff on proper aseptic technique and sample collection.
Coram CVS/specialty infusion services is a Fortune 7 company and national leader in the home infusion and enteral fields. This is uniquely rewarding opportunity putting your skills and experiences to work supporting an innovative specialty pharmacy operation.
Learn more about us: https://www.youtube.com/user/CoramHealthcare or https://www.youtube.com/user/CVSPharmacyVideos
A little about us: