Micro QC Analyst

Description:

JOB TITLE Micro QC Analyst I

DEPARTMENT QC Microbiology

SUMMARY 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.

• 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.

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.

• 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.

• 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.
• 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 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

Problem-solving skills

Strong communicator

Works independently

Working knowledge of Word, Excel and Power Point