The Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. The Laboratory Technician position at the Elkton, Virginia Manufacturing site is a key contributor in our Quality Operations units that helps ensure products made are safe and compliant. Laboratory Technician role will work primarily within the grade facility in an aseptic manner, requiring gowning. This person works on shift potentially alone or with one other person.
" Collecting environmental monitoring samples (viable surface/air and non-viable air) of process areas " Environmental monitoring plate reads " Gowning training and certifications " Microbiological and chemical sampling of process water " Clean steam and compressed gas sampling and testing " Data management activities " Facilities qualification testing " Assisting with protocol testing as needed " Prepping and maintenance of all supplies and equipment " Utilizing standard operating procedures to perform their work and making updates to those procedures when necessary in alignment with management
The CEMS will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned IPT. Specific responsibilities include but are not limited to the following:
Monitor environmental performance against specifications within classified areas. Provide environmental support to manufacturing and testing areas as needed. Perform investigations into environmental excursions. Actively participates in the Tier process and uses this forum to escalate concerns and best practices. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Adherence to SOPs, GMPs and safety procedures. Author environmental project protocols and reports.
Education: B.S. degree in Chemistry, Biology, Microbiology or related sciences is required. Experience Required: " Capable of working alone, and managing work loaded that is directed " Computer skills are required, should be proficient in standard laboratory techniques and laboratory data management systems Preferred Skills: " Lab data management systems " Microbiology and aseptic technique is advantageous and raining will be provided " cGMP " Previous laboratory work " Proficient in standard laboratory techniques and laboratory data management systems. " Role requires the ability to read and write in the English language Work Schedule: 12 hour rotating shift; days and nights (6am-6pm or 6pm-6am). IMPORTANT: ** Expected to work in an environment with potential beta-lactam antibiotic exposure **