QC Microbiology Analyst

About the role

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

Responsibilities

• Various Microbial testing
• EM monitoring of the aseptic production areas
• Ordering and stocking supplies
• Creating/reviewing SOPs
• Investigation writing
• 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

Shift Information

Two possible shifts: Monday - Friday from 7:00 am to 3:30 pm, or Monday - Friday from 10:00 am to 6:30 pm. Some flex in the start and end times may be allowed; weekend work and overtime as required.

Qualifications

• Previous quality control microbiology experience required
• BA/BS in Microbiology/Biology with 2+ years' experience in CGMP, pharma, or lab environment required
• Practical experience in general microbiology laboratory techniques working with bacteria, yeast, and mold
• Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas
• 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

Preferred Experience

• Experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon or endotoxin assays
• SOP review, creation and approval
• OOS investigations writing
• Prior experience with data review, authoring SOPs, Change Controls, out-of-specification investigations, and report writing

Key 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

Physical Requirements

• Capacity to lift and carry up to 20 pounds
• Kneel, reach and stretch
• Stand for at least 4 hours