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27 Jul 2020

Full-Time Senior Specialist, QC Microbiology (2nd Shift)

annjaclyn – Posted by annjaclyn Anywhere

Job Description

Contribute to outstanding innovation + Make braver choices

 

Senior Specialist, QC Microbiology (2nd shift)

Location: Parsippany
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.

 

Summary:

 

To perform Quality Control Microbiology testing for in-process and routine release testing, Environmental/Water Sampling, method development, report and author non-conformances, deviations and CAPA’s, perform trend reports and train new hires. SME in one or more disciplines in the area of Microbiology.

Responsibilities:

o    Perform routine and process environmental monitoring in aseptic manufacturing environment.

o    Perform clean utilities (compressed air, Nitrogen, WFI/DIW and Clean Steam) sampling and testing.

o    Perform Bioburden, Endotoxin, Total Plate Count, Coliform, Bacteriostasis & Fungistasis (B&F) and Biological Indicator testing, and Plate Reading

o    Write/review material specifications and perform material qualifications (media and reagents).

o    Initiate and investigate microbiology related deviations (NCEs), OOS investigations, and implementing appropriate CAPAs as needed.

o    Operate Sterility Isolator and perform routine maintenance and testing as needed.

o    Perform routine QC responsibilities such as sample coordination, peer review, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents, as needed.

o    Monitor laboratory equipment for temperature, humidity, etc., and conformance to specifications

o    Specializes in method development of microbiological methods in one or more disciplines of Microbiology. Able to develop methods of new products/components, author protocols and test methods, execute and troubleshoot findings.

o    Subject matter expert in one or more fields of microbiology (i.e., BET, Bioburden Testing, AET, Microbial Identification, Sterility Testing, LIMS). Highly skilled in training

Requirements:

o    Bachelor’s degree in a Microbiology, health sciences or natural sciences from an accredited college or university

o    A minimum of 3-5 years in a GMP, QC Micro Analyst role or in biotechnology or pharmaceutical industry

o    Working knowledge following Standard Operating Procedure (SOP) and microbiology test methods and generally accepted laboratory practices

o    Strong verbal and written communication with ability to communicate complex ideas and concepts.

o    Strong attention to detail, i.e. reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.

o    Comfortable with computerized data storage programs such as GLIMs

o    Flexibility in work schedule

o    Ability to effectively negotiate and influence key partners and suppliers to meet requirements and commitments.

o    Ability to train and mentor colleagues

o    Drive for Results

o    Ability to stand on feet for up to four hours at a time;

o    Be able to lift, push, and /or pull up to 25 pounds;

o    Be able to independently gown for aseptic processing;

o    Meet minimal visual acuity requirements necessary for quality

o    Able to move freely around in a manufacturing environment, including moving about on stairs, and ladders, and in an around machines with moving parts.

Join our team and you’ll become part of a close-knit family – one in which you’ll be listened
to and your contributions valued. Surrounded by like-minded people, you’ll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected
Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.                                                     

 

How to Apply

Please apply via the link below: https://ferring.wd3.myworkdayjobs.com/en-US/Ferring/job/Parsippany/Senior-Specialist--QC-Microbiology_R0014237

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: 40,000 - 60,000.

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