Micro QC Analyst I

About the role

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.

Responsibilities

• Previous quality control microbiology experience required
• Experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon or endotoxin assays preferred
• Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas
• SOP review, creation and approval preferred
• OOS investigations writing 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

Analyst Qualifications

• 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

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
• 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

Qualifications

• 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 PowerPoint
• 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

Skills

• Microbiology
• Laboratory Information Management Systems (LIMS)
• SOP Development
• Good Manufacturing Practices (GMP)