Environmental Monitoring

Schedule Day shift Monday to Friday Night shift Weekend availability Benefits 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health Insurance Life Insurance Paid time off Vision Insurance program About the Job The Environmental Monitoring (EM) Technician is responsible for performing routine and batch-related Environmental Monitoring in the cleanroom, laminar flow hoods, and other controlled environments, following current Good Manufacturing Practices. This position will work under the direction of the Quality Control Manager. Responsibilities Perform Environmental Monitoring (EM) in an aseptic environment (batch, routine, gowning monitoring, and utility testing). Performs Daily, Weekly, Monthly, and Quarterly EM. Performs viable air, non-viable particle counts, and contact surface testing. Completes all necessary documentation on GMP documents in real-time. Responsible for the accurate recording, review, and storage of laboratory data. Implement Data Integrity 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. Ship QC equipment for calibration as required per established policies and procedures. 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. Assist with facility qualification and validation as required. Ensure proper equipment function, calibration, maintenance, and troubleshooting of laboratory equipment. Assist with the initiation of investigations/deviations and the determination of root causes analysis. Participate in hazardous waste training. Transfer of hazardous waste between lab and trash accumulation area/storage. Seeks continuous improvement within EM related activities. Initiates the review/revision of EM related Standard Operating Procedures (SOPs). Supports the QC Manager in projects relating to EM technician tasks. Follow best practices, quality trends, and regulatory requirements. Follows Standard Operating Procedures designed to ensure quality in EM tasks, consistent with established standards in Well’s Pharma. Ensures compliance with US Food, Drug & Cosmetic Act. Perform additional duties as required and assigned by the Quality Control Manager, such as but not limited to the following: Other Duties Receive and inspect incoming shipments of GMP materials and equipment following established procedures and Certificate of Analysis. Prepare and sign-out raw materials, samples, finished product, etc. to Manufacturing and Quality, ensuring proper procedure and temperature range are followed. Ensure QC department supplies are inventoried and ordered to avoid stock‑out. Maintains control of all Sample Retain containers from receipt to disposal. Participates in the receiving of Sample Retains from operations. Organize and submit in-process and final‑release Sample Retains for shipping to a contract lab for testing. Liaise between Operations and QC as pertains to Sample Retains. Organize and maintain Sample Retain logs on Microsoft Excel. Maintain the Sample Retain inventory room, refrigerators, and freezers. Record the daily storage temperatures of incubators, refrigerators, and freezers. Ensure that Sample Retains are stored in appropriate locations. Ensures adequate storage areas are available in each sample storage area. Ensure Sample Retains are readily available for Shipping with proper documentation. Prepare for shipping testing to contract labs for chemistry and microbiology samples. Dispose of Sample Retains in accordance with cGMP regulations after retention time has passed. Organize Sample Retains by lot/batch number, documenting the storage location in logbooks/excel for ease of retrieval. Knowledge, Skills & Abilities Knowledge of cGMP regulations, FDA CFR Title 21 part 210 and 211. Strong verbal, written communication skills and computer skills are required. Must be goal‑oriented, quality‑conscientious, and customer‑focused. Proficiency in Excel is highly desirable. Knowledge of laboratory science and aseptic techniques principles. Effective oral and written communication skills. Ability to read, understand, and follow work instructions and laboratory test methods. Ability to work independently and cooperatively on a team. Education & Experience Associates degree or Bachelor’s in Microbiology or closely related field is strongly preferred, or equivalent combination of education and experience. A minimum experience of 1 year in the pharmaceutical and biopharmaceutical industry. Working Conditions Working conditions vary; work may be performed in but is not limited to the aseptic area, mechanical areas, and laboratory. Laboratory and cleanroom setting: Will be exposed to bio‑hazardous materials, hazardous waste, and pharmaceuticals. #J-18808-Ljbffr Wellspharmatx