Manufacturing Associate

We are seeking Manufacturing Associates Level 1 to support kitting, labeling, packaging, and aseptic manufacturing operations for LAL products. The role will initially focus on the kitting and labeling department, including packaging and labeling 2–30 mL vials. Candidates with approximately one year of experience in Good Documentation Practices (GDP) are preferred to ensure a basic understanding of documentation requirements in a regulated manufacturing environment. As the role evolves, based on performance and qualifications, opportunities may be available to advance to higher-level manufacturing positions or transition to the third shift. Additional pay increases are available for third-shift work and gowning qualification. Key Responsibilities Participate in upstream and/or downstream aseptic manufacturing of LAL products in an ISO 5 environment. Set up and operate production equipment in the LAL Filling and Finishing areas. Perform product inspections and final kit packaging of finished goods. Perform kitting, labeling, and packaging of 2–30 mL vials. Follow company and departmental Standard Operating Procedures (SOPs). Complete production records accurately and maintain Good Manufacturing Practices (GMP) documentation. Perform environmental monitoring activities and follow aseptic processing and gowning requirements. Complete product sample submissions and inspection proficiency testing. Support continuous improvement initiatives and maintain compliance with safety policies. Perform other duties as assigned. Training and Qualification Requirements LAL Cleanroom General Training. Aseptic processing and gowning. Cleanroom equipment setup and usage. LAL Finishing General Training. Finishing equipment setup and usage. Qualification on relevant SAP transactions: LAL Manufacturing: COR3, COR6, MIGO, LS26. LAL Finishing: COR2, COR6, MIGO, MB1A, LB01, LS26. GMP documentation practices. Product sample submission and inspection process. Component kitting process. Performance Expectations Maintain a safe work culture through safety discussions, safety observations, and 6S practices. Demonstrate a basic understanding of the LAL manufacturing process flow. Perform job functions with minimal operator-related process reports (PRs). Perform aseptic processing with minimal operator-related personnel excursions identified through environmental monitoring (EM). Maintain accurate GMP documentation with minimal documentation errors. Follow SOPs and complete production records accurately. Demonstrate compliance with GMP requirements in a manufacturing environment. Achieve annual personnel utilization targets. Maintain training compliance and meet yearly training targets. Comply with all safety policies and general regulations. Required Qualifications Approximately 1 year of experience with Good Documentation Practices (GDP) preferred. Basic understanding of GMP documentation and regulated manufacturing processes. Ability to follow written procedures and accurately complete production documentation. Willingness to work in a cleanroom environment and complete gowning and aseptic processing training. Strong attention to detail, particularly when handling, labeling, inspecting, and packaging vials. Willingness to work onsite in Walkersville, MD. #J-18808-Ljbffr VIVOS Professional Services, LLC