Manufacturing Associate Level 1

Bot Verification•Walkersville, MD

3d•Onsite

About The Position

The Manufacturing Associate Level 1 participates in upstream and/or downstream aseptic manufacturing of LAL products in an ISO 5 environment, following company and departmental standard operating procedures. The role sets up and operates production equipment in LAL Filling and Finishing, inspects products, and packages finished goods into final kits. The associate performs work under direct supervision, with close monitoring and guidance from the team. The position handles high-volume issues of low complexity and contributes as an individual contributor without direct or indirect reports or a spending budget. Work is guided by the production schedule, goals, objectives, and product-specific standards and protocols.

Requirements

Basic technical and scientific knowledge.
Basic process knowledge, basic math skills, and basic computer skills.
Familiarity with laboratory techniques and practices, including basic GMP and GDP.
Ability to complete standard tasks by applying basic principles and researching and interpreting factual information.
Ability to work on problems of limited scope, use minimal discretion for basic tasks, and perform minimal troubleshooting by following instructions.
Ability to follow product-specific standards, protocols, processes, SOPs, and production records.
Ability to work under direct supervision and rely on the team for direction.
Ability to maintain 90% accuracy in tasks and information provided.

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.
Contribute to a safe work culture through safety chats, safety and EPS observations, and 6S.
Complete required cleanroom, aseptic processing, gowning, equipment, environmental monitoring, finishing, and SAP transaction qualifications.
Follow GMP documentation practices, standard operating procedures, and production records requirements while minimizing documentation errors.
Submit product samples and complete inspection proficiency testing, inspection processes, and component kitting.
Participate in continuous improvement projects.
Perform aseptic processing while minimizing operator-related personnel excursions and perform job functions while minimizing operator-related PRs.
Understand the basic LAL process flow.
Meet yearly personnel utilization and training compliance targets.
Comply with safety policies, general regulations, and GMP requirements in the manufacturing environment.
Perform other duties as assigned.