Technician, QC Microbiology - 2nd Shift | BioNJ Talent Services

Technician, QC Microbiology - 2nd Shift

Contact Information
Contact Name: 
Ferring Pharmaceuticals
Organization Name: 
Ferring Pharmaceuticals
Position Location: 
Parsippany
Company Profile: 

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 over 5,700 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) and orthopaedics. Ferring’s US operations employ approximately 800 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.

Job Description:

Summary:

Work in a cGMP-compliant manner in support of production, facilities, clean utilities and general microbial testing on second shift. Participate in assay transfer processes and qualification of equipment. Create/Revise equipment qualification protocols, test methods, and procedures as required. Work independently with minimal supervisory guidance. Apply aseptic clean room practices during execution of all work tasks. Must have prior clean room aseptic sampling experience in water and environmental monitoring.

Responsibilities:

•Create/revise documents. i.e. SOPs and material specifications, investigations, protocols, and trend reports (water, environmental monitoring, or invalid assays).
•Perform process environmental monitoring (EM) during aseptic cleanroom filling operations. This includes air sampling (viable and non-viable), surface sampling and personnel sampling. Must have experience in aseptic gowning and working RAB enclosures.
•Perform routine (EM) of fill rooms, ancillary room and compounding areas. Apply aseptic clean room practices during execution of all work tasks.
•Perform water sampling all utilities (water/gas) for both Mfg and QC labs.
•Perform General Microbiological Testing such as Bioburden, Endotoxin, sterile hold test, total plate count (TPC), Sterility testing, Coliform and biological indicator. Monitor and identify trends.
•Perform Microbial identification using Vitek II.
•Prepare and maintain microbial stock culture and perform Methods suitability (Bacteriostasis/Fungistasis (B&F)) testing.
•Routinely perform QC Microbiology inventory control.
•Assist in special projects (i.e. validations, microbiological studies, etc.).
•Work 2nd Shift 3:00 PM – 11:00 PM and may have to come in early and stay late to support production, clean utilities, facilities and microbiology lab functions.
•Work weekends, overtime, and holidays, as needed.

Qualifications: 

Requirements:

•B.S. Degree with 1-5 years of previous experience with aseptic pharmaceutical experience.
•Must have experience in aseptic gowning and working in RAB enclosures.
•Knowledge of cGMP, USP, EU, JP and the ISO regulations is preferred.
•Excellent teamwork, written and oral communication skills. Attentive to detail.
•Ability to work independently and achieve problem resolution with minimal supervision.
•Competent in use of Microsoft Office programs, LIMS, and QMAS.
•Wear protective or safety equipment such as safety shoes, glasses, gloves.
•Work indoors in an environmentally controlled area.
•Climb and move about in an environment among machines with moving parts and ladders/stairs.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Control