Specialist, QC Micro

Ferring Pharmaceuticals, Inc. Parsippany , NJ 07054

Posted 2 weeks ago

Job Title:Specialist, QC Micro

Job Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology), orthopedics and Oncology. Ferring's US operations employ approximately 900 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

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:

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

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

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

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

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

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

  • 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.

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

  • 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.

  • 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:

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

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

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

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

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

  • Comfortable with computerized data storage programs such as GLIMs

  • Flexibility in work schedule

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

  • Ability to train and mentor colleagues

  • Drive for Results

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

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

  • Be able to independently gown for aseptic processing;

  • Meet minimal visual acuity requirements necessary for quality

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

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.

If you need assistance during the application process due to a disability, please email careers@ferring.com

Location:Parsippany


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Specialist, QC Micro

Ferring Pharmaceuticals, Inc.