Microbiologist FL

PL Developments Careers•Miami, FL

3d•Onsite

About The Position

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. SUMMARY: We are seeking a detail-oriented Microbiologist to join our Pharmaceutical Quality Control Laboratory. In this role, you will be responsible for performing microbiological testing to support the manufacture and release of pharmaceutical products. Responsibilities include environmental monitoring, bioburden and endotoxin testing, microbial identification, and maintaining compliance with cGMP standards. The ideal candidate will have a strong background in microbiology, experience in a regulated lab environment, and a commitment to quality and data integrity. Work Schedule: Monday - Friday 8:00 AM - 4:30 PM

Requirements

Bachelor’s degree in Biology, Microbiology, discipline with two years’ experience in a relevant Microbiology laboratory environment (e.g. Pharmaceutical, Quality, Clinical, sterile manufacturing or lab operation) or Master Degree in Biology, Microbiology
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 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)
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.

Nice To Haves

Experience in regulated/cGMP environment highly preferred

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.