Microbiology Supervisor Job Fort Worth area,Texas USA,Healthcare

summary/objective

The Microbiologist Supervisor is responsible for leading the microbiology laboratory in day-to-day activities, such as ensuring all raw materials, finished products, stability program samples, and research/validation batches are

tested within company-mandated time periods. The Microbiology Supervisor may also serve as the stand-in

approver when the Microbiology Manager is out of the office. The Microbiology Supervisor will delegate or, when necessary, complete the following task-related activities listed below:

essential functions

Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations

Direct training as the subject matter expert of all microbiologists and maintain training documents

Update the Associate Director of Quality Systems / Microbiology, QA and other plant management on microbiology testing and related activities

Ensure the following microbiological testing related to the following microbiological test methods is either completed or performed by the microbiologists:

Microbial Enumeration and Specified Microorganism (MET / SMT) testing per USP /
Antimicrobial Effectiveness Testing (AET) per USP
Preservative Effectiveness Testing (PET) per USP
Purified/Source Water testing per USP
Environmental Monitoring (EM)
Water Activity Determination per USP
Cleaning validation/verification microbiological recovery testing
Isolate identification testing using the VITEK 2 Compact Isolate Identification System
Microbiological growth promotion and sterility verification testing

Initiate, revise, or review the following Plant-controlled documents to ensure they are current and in compliance:

SOPs, forms, and logbooks,
Specifications
Change Controls
Microbiology Investigations / Deviations

Initiate and perform the following validation activities:

Critical Systems Qualification of Equipment and/or Production Controlled Rooms
Test Method Validation
Preservative Effectiveness Studies

Approve/review microbiology test records and logbooks

Maintain and coordinate equipment/instrumentation maintenance, calibration, and repair work

Contact media and supply vendors to troubleshoot issues

Schedule and approve scheduled time off by microbiologists

Schedule and ensure the following microbiology activities are promptly and compliantly performed by the microbiologists: (This list is not designed to cover all activities, duties or responsibilities)

Purified water system testing on required intervals
Environmental monitoring testing on required intervals
Isolate Identifications on Vitek m
Initiate Isolate Identification Reports when necessary
Updating, reviewing, and approving microbiological trending
Approve/review daily temperature readings
Controlled substance compliance
Media and supply inventory maintenance, including ordering and releasing media, buffers, and microorganism cultures
Cleaning and sanitization activities in the microbiology laboratory

required education and experience

Bachelor's degree in microbiology, biology, or related scientific field or equivalent experience
Seven (7) to ten (10) years of experience in a pharmaceutical microbiology laboratory
Knowledge of cGMP/GLP/GDP, USP / EU regulatory requirements
Experience performing microbiological testing / environmental monitoring using aseptic techniques
Excellent technical writing, project management, and organizational skills
Excellent interpersonal communication and organizational skills
Qualified to work with controlled substances
Knowledge and experience performing serial dilutions
Experience Handling Biohazardous materials
Knowledge of USP, EU, and FDA requirements related to the position
Experience with regulatory audits

position type/expected hours of work

This is a full-time position on 1st shift and days/hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required when the production needs exist or until the daily tasks or goals are met.

physical demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is required to sit at a computer for long periods of time and occasionally required to stand for long periods of time collecting or processing samples. Specific vision abilities required by this position include close vision and color vision.

work

environment

This job operates in a professional office environment and business casual attire with socks and closed toe shoes is required. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This role requires good hygiene and hair / facial hair must be kept well-trimmed to prevent incidental contamination during testing. Working with Biohazardous materials is also prominent.

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