Sanofi Group Quality Control Analyst I in Ridgefield, New Jersey
Job Title: Micro QC Analyst I
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.
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.
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; weekend work and overtime as required.
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
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.
- 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.
EDUCATION & EXPERIENCE:
BA/BS in Microbiology/Biology with 2+ years’ 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
Working knowledge of Word, Excel and PowerPoint
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.