Job Details

Job Type

Full-time

Description

Founded in 2015, Medivant set up a greenfield manufacturing facility in 2020 which is now validated and fully operational. At Medivant Healthcare, we believe in the power of delivering high quality products at an affordable price to meet the needs of hospitals, healthcare providers and the patients they serve.

• We have an opening for full-time Microbiologist positions.
• Location: 24416 N 19th Ave Phoenix, AZ 85085 & 158 S Kyrene Rd Chandler, AZ 85226 (you will be working in both locations)
• Schedule: F/T: Monday through Friday during training, then Wednesday through Sunday as needed. More details to be provided during the interview.
• Benefits: Health, Dental, Vision, LTD, STD, Accident, Life and 401K with 3% match
• Salary: $55k-$60k

Roles and Responsibilities

• Performing routine- and process-based environmental and personnel monitoring in aseptic manufacturing environment.
• Performing Bioburden, Endotoxin, Total Plate Count, Coliform, Biological Indicator testing, and Plate Reading.
• Perform sterility testing of finished product.
• Ensuring ongoing stability testing of products, communicating with other team members to solve problems.
• Writing and reviewing material specifications and performing material qualifications (media and reagents), writing reports, sending emails.
• Initiating and investigating microbiology related deviations, OOS investigations, and implementing appropriate CAPAs as needed.
• Performing routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents, as needed.
• Assisting QA in qualifying suppliers and vendors.
• Monitoring laboratory equipment for temperature, humidity, etc., and conformance to specifications.
• Able to develop methods of new products/components, author protocols and test methods, execute and troubleshoot findings.
• Assisting in the training of new hired QC staff and/or microbiologists
• Performing other duties as requested, directed, or assigned.

Requirements

In order to be successful in this position, you'll need to have the following:

• Bachelor's Degree in Natural Sciences (Biology, Microbiology, Medical Technology)
• At least 1-2 years of experience working in a microbiology, chemical, analytical laboratory; working with a registered quality system in pharmaceutical production and/or manufacturing environment and/or FDA Good Manufacturing Practices and regulatory audits preferred.
• Basic knowledge on Microbiological Laboratory Techniques and equipment required
• Specialized knowledge and/or experience in method development of microbiological methods in one or more disciplines of Microbiology preferred
• Very strong Microsoft Office Suite skills (Word, Excel, Outlook, etc) and the ability to learn and operate other specific applications and software.
• Able to read, write, and speak English Fluently
• Able to travel to both of our facilities

Specific role requirements

Given the specifics of the position and the environment, you'll need to:

• Microbiological Analysis of Potable and Purified water.
• Environmental Monitoring of Production area as well as Microbiology Laboratory.
• Microbiological Analysis of Raw Materials and Finished Products (Microbial Limit Test).
• Sterility Testing.
• Bacterial Endotoxin test.
• Media Preparation and Growth Promotion Test of Medias.
• Bioload of Packaging Materials.
• Bioload of Equipments and Operators by Contact Plate Technique.
• Preservative Efficacy Test.
• Disinfectant Efficacy test.
• Subculturing and Culture Dilution.
• Maintenance of Media Stock.
• Microbial Method Validations of Raw Materials and Finished Products.
• Viability of Biological Indicators and Stock Maintenance.
• Preparation of Master Standard Operating Procedures, Equipment operating procedures, Instrument operating procedures.
• Preparation of Master Test Data Sheets and Validation Protocol and Reports.
• Preparation of Environment and Water Trends.
• Handling of Out Of Specification and preparation of Corrective and Preventive Action.
• Work Allocation and Manpower Handling.
• Review of all department related SOPs and updation.
• Responsible for Change controls for microbiology.
• Responsible for handling of deviation for microbiology.
• Responsible for OOS investigation in Microbiology.
• Responsible for CAPA in Microbiology Lab.
• Checking of reports of MLT, Antibiotic Assay, Sterility, BET, water analysis, Environment monitoring etc.
• Review of Trends for water and environment.
• Review of Medial fill activities and documents and active participation in media fill.
• Sterility assurance of aseptically filled product.
• Review of Area qualification documents and gowning qualification documents for aseptic area.
• Responsible for overall responsibilities of microbiology department.

Salary Description

$55,000-$60,000