Direct message the job poster from Staffing Resource Group, Inc

Job Description

Microbiologist

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Microbiologist
  • Location: Miami, FL
  • Industry: Pharmaceutical
  • Hours: Monday-Friday 7am-3:30pm or 11:30am-8pm (possible flex schedule)
  • Salary: Up to $70,000 depending on experience
  • Employment Type: Direct hire with benefits

TOP QUALITIES INCLUDE:

  • Thorough knowledge and understanding of current Good Manufacturing Practices (cGMP), FDA Guidance, and ICH Guidelines
  • Strong microbiology skills with a focus on drug product contamination control and environmental microbiology
  • Experience in the use and handling of standard instrumentation used for Microbiological and EM sampling and testing
  • Experience in regulated/cGMP environment highly preferred
  • Experience working with Quality Systems in GMP regulated operations such as Change Control, Deviation / Investigation, CAPA s and other quality systems
  • Time management and prioritization
  • Excellent oral and written communication
  • Attention to detail and ability to perform job function with minimal supervision
  • Critical thinking, problem solving, and analytical thinking applied to data and diverse situations
  • Proficient in computer applications (Word, Excel and Power Point)

POSITION RESPONSIBILITIES:

  • Collects samples from a variety of locations
  • Coordinate sample shipping to external laboratories, coordinate testing schedule and review /approve test results.
  • Run the Environmental Monitoring Program (EM) in terms of Test & Data Management
  • Run the Purified Water (PW) Monitoring Program in terms of Test & Data Management.
  • Perform Environmental Monitoring tasks as needed.
  • Generate quarterly EM and PW reports
  • Lead EM excursion Deviations and associated CAPAs
  • Provide technical Support (from Microbiology and Aseptic Technics perspective) to Manufacturing operation.
  • Develop Risk assessment from Micro/EM perspective to support changes to the controlled areas and/or process that are conducted on it.
  • Function as the Micro Laboratory liaison and subject matter expert (SME) to other department representatives, customers and regulatory representatives.
  • Provides remediation solutions to Laboratory and operations area on Microbiology related issues
  • Scheduling Micro laboratory equipment maintenance, calibration and repairs ensuring minimum impact to the Lab and Manufacturing
  • Contact person with Laboratory Service provider company
  • Perform all other tasks that will be oriented by the QC Supervisor, QC Manager or the Quality Director

PHYSICAL REQUIREMENTS:

  • Work safely and follow all OSHA regulations and company safety policies and procedures
  • Works frequently in a lab environment, handling of chemicals
  • Employees are required to wear eye protection and lab coats while in the lab area
  • Ability to frequently lift and/or move up to 25 lbs
  • Ability to occasionally lift and/or move up to 35 lbs
  • Ability to regularly stand, sit, and walk to perform tasks

QUALIFICATIONS

  • Bachelor s degree in Biology, Microbiology, discipline with three years experience in a relevant Microbiology laboratory environment (e.g. Pharmaceutical, Quality, Clinical, sterile manufacturing or lab operation) or Master Degree in Biology, Microbiology
  • Strong Microbiology Skills with a focus on Drug Product Contamination Control and Environmental Microbiology
  • Handling of Standard Instrumentation used for Microbiological and EM Sampling and Testing
  • Experience in Regulated/cGMP Environment

ADA/EOE

  • Seniority level

    Entry level
  • Employment type

    Full-time
  • Job function

    Science and Other
  • Industries

    Pharmaceutical Manufacturing

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