QC Microbiology Technician

Role Summary

The QC Microbiology Technician is responsible for assisting routine and batch-related Environmental Monitoring in controlled environments, following current Good Manufacturing Practices.

Responsibilities

• Completes all necessary documentation on GMP documents in real-time.
• Responsible for the accurate recording, review, and storage of laboratory data.
• Strictly follow Data Integrity principles for reliable, accurate, and complete laboratory data.
• Assist with the setup and daily running of the EM laboratory.
• Participate in EM lab operations on a daily, weekly, monthly, and quarterly schedule.
• Incubate and enumerate organisms on cultured media.
• Prepare for shipping to a contract lab, Out-of-Specification (OOS) media plates, and finished product.
• Provide EM support including review, tracking of EM of Microbiology results in support of product release. In conjunction with Quality Assurance, ensure timely completion and data review of routine and batch-related microbiological data.
• Contributes to the gowning qualification program by taking samples and analyzing data.
• Identify process improvements.
• Ensure proper equipment function, calibration, maintenance, and troubleshooting of laboratory equipment.
• Participate in hazardous waste training. Transfer of hazardous waste between lab and trash accumulation area/storage.
• Supports the QC Micro Management in projects relating to EM technician tasks.
• Follow best practices and regulatory requirements.
• Follows Standard Operating Procedures designed to ensure quality in EM tasks.
• Perform monthly review of laboratory equipment logbooks and perform monthly laboratory cleaning.
• Perform quarterly equipment cleaning.
• Perform additional duties as required and assigned by the Quality Control Management, such as but not limited to the following:
• Receive and inspect incoming shipments of GMP materials and equipment following established procedures and Certificate of Analysis.
• Ensure QC Micro department supplies are inventoried and ordered to avoid stock-out.

Qualifications

• Preferred: Associate's degree or Bachelor's in Microbiology or closely related field, or equivalent combination of education and experience.
• Preferred: Minimum 1 year of experience in the pharmaceutical and biopharmaceutical industry.
• Preferred: Knowledge of LIMS.
• Preferred: Knowledge and understanding of cGMPs and GLPs used in the industry.
• Preferred: Detail oriented with expertise in problem solving and solid decision-making abilities.
• Preferred: Strong interpersonal skills including a professional demeanor when interacting with colleagues.

Education

• Associates degree or Bachelor’s in Microbiology or closely related field is strongly preferred, or equivalent combination of education and experience.

Skills

• Must be goal-oriented, quality-conscientious, and customer-focused.
• Knowledge of laboratory science and aseptic techniques and principles.
• Effective oral and written communication skills.
• Ability to read, understand, and follow SOPs, work instructions and laboratory test methods.
• Ability to work independently and cooperatively on a team.