Quality Control Analyst I

Job Title: Quality Control Analyst I

Location: Ridgefield, NJ

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Micro QC Analyst I is dedicated to the Microbiology Laboratory and EM Monitoring Program.  The role of the Micro QC Analyst I will be that of various Microbial testing, EM monitoring of the aseptic production areas, ordering and stocking supplies, creating/reviewing SOPs, investigation writing, data entry. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

The Micro QC Analyst I is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing the day-to-day operation, testing and EM monitoring for the Micro team.

• The candidate must have previous quality control microbiology experience. Experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon or endotoxin assays is preferred

• Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.

• SOP review, creation and approval is preferred

• OOS investigations writing is preferred 

• Basic knowledge of compliance with all cGMP standards, safety and environmental regulations and company SOPs.   

• Data entry of EM sampling results, LIMS, logbooks, and other miscellaneous lab data. 

• Interact with Project Teams and cross-functional groups related to site operations

• Cohesive Micro player in the Micro department who is willing to assist or help a fellow analyst.

The Micro QC Analyst I is expected to act on and demonstrate the Sanofi LEAD competencies:

• Act for Change: Embrace change and innovation and initiate new and improved ways of working.

• Cooperate transversally: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.

• Develop People: Take responsibility for developing one’s self and mentor other Micro Personnel in anticipation of future business needs or to assist the micro department.

About You

HSE

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.

• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.

• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

Education / Experience

Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours.

• BA/BS in Microbiology/Biology with at least 1 year of experience in CGMP, pharma or lab environment is required.

• Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold.

• Prior experience with data review, authoring SOPS, Change Controls, out of specification investigations and report writing is recommended. 

• Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing

• Excellent technical writing skills

• Ability to collaborate effectively with personnel and between departments

• Problem-solving skills

• Strong communicator

• Works independently

• Working knowledge of Word, Excel and PowerPoint­­­­­­

Working Hours

Consist of two possible shifts

• Monday - Friday from 7:00 am to 3:30 pm, or  Monday - Friday form 10:00 am to 6:30 pm

• Some flex in the start and end times may be allowed;