Job Description
<b>Job Description Summary</b>The QC Microbiology Technician is responsible for assisting routine and batch-related Environmental Monitoring in controlled environments, following current Good Manufacturing Practices.<br> <b>Job Description</b><b>LOCATION:</b> This opportunity is located in Morris Plains, NJ and will not have the ability to be located remotely.<b>Number of positions available:</b> 10<b>Shifts available: </b>Friday - Monday (four 10-hour days) - 7 positions availableSunday - Thursday OR Tuesday - Saturday (8:00am - 4:30pm) - 3 positions available<b>Essential Duties & Responsibilities</b><ul><li>Completes all necessary documentation on GMP documents in real-time.</li><li>Responsible for the accurate recording, review, and storage of laboratory data.</li><li>Strictly follow Data Integrity principles for reliable, accurate, and complete laboratory data.</li><li>Assist with the setup and daily running of the EM laboratory.</li><li>Participate in EM lab operations on a daily, weekly, monthly, and quarterly schedule.</li><li>Incubate and enumerate organisms on cultured media.</li><li>Prepare for shipping to a contract lab, Out-of-Specification (OOS) media plates, and finished product.</li><li>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.</li><li>Contributes to the gowning qualification program by taking samples and analyzing data.</li><li>Identify process improvements.</li><li>Ensure proper equipment function, calibration, maintenance, and troubleshooting of laboratory equipment.</li><li>Participate in hazardous waste training. Transfer of hazardous waste between lab and trash accumulation area/storage.</li><li>Seeks continuous improvement within EM related activities.</li><li>Supports the QC Micro Management in projects relating to EM technician tasks.</li><li>Follow best practices and regulatory requirements.</li><li>Follows Standard Operating Procedures designed to ensure quality in EM tasks.</li><li>Perform monthly review of laboratory equipment logbooks and perform monthly laboratory cleaning.</li><li>Perform quarterly equipment cleaning.</li><li>Perform additional duties as required and assigned by the Quality Control Management, such as but not limited to the following:</li><li>Receive and inspect incoming shipments of GMP materials and equipment following established procedures and Certificate of Analysis.</li><li>Ensure QC Micro department supplies are inventoried and ordered to avoid stock-out.</li></ul><b>Knowledge, Skills & Abilities</b><ul><li>Must be goal-oriented, <span>quality-conscientious,</span> and customer-focused.</li><li>Knowledge of laboratory science and aseptic techniques and principles.</li><li>Effective oral and written communication skills.</li><li>Ability to read, understand, and follow SOPs, work instructions and laboratory test methods.</li><li>Ability to work independently and cooperatively on a team.</li></ul><b>Core Values</b><ul><li>Consistently operate with the highest standards of ethics and compliance.</li><li>Take ownership of your actions, success and setbacks.</li></ul><b>Ideal Background:</b><b>Education & Experience</b><ul><li>Associates degree or Bachelor's in Microbiology or closely related field is strongly preferred, or equivalent combination of education and experience.</li><li>A minimum experience of 1 year in the pharmaceutical and biopharmaceutical industry is preferred.</li><li>Knowledge of LIMS preferred.</li><li>Knowledge and understanding of cGMPs and understanding of GLPs used in the industry preferred.</li><li>Detail oriented with expertise in problem solving and solid decision-making abilities.</li><li>Strong interpersonal skills which inclu