Manufacturing Associate - Applied BioCode Inc

Manufacture barcoded magnetic beads (BMBs), immuno-chemistry and molecular reagents, in-vitro diagnostic (IVD) and research use only (RUO) products.

Responsibilities

• Responsible for production of BMBs, preparation of reagents used in manufacturing Applied BioCode IVD, ASR, and RUO products.
• Complete and maintain Quality Records in compliance with regulatory requirements and standard operating procedures.
• Perform process optimization, validation, calibration, and stability studies.
• Make detailed observations, analyze data using statistical methods, interpret results, document conclusions, prepare technical reports.
• Perform production duties in manufacturing such as labeling and packaging.
• Maintain production data entry in ERP system.
• Maintain clear and accurate documentation (DMR).
• Maintain adequate supplies and tools.
• Calibrate, monitor, and ensure equipment performance.
• Contribute ideas toward process improvement.
• Execute Cycle Counting and Physical Inventory
• Meets deadlines specified in overall project schedules.

Maintain a high degree of safety awareness and a clean orderly work area.

Qualifications

• Bachelor's degree or equivalent experience
• Working knowledge of IVD manufacturing, cGMP, and QSR.
• Basic knowledge of molecular chemistry principles, theories, and practices.
• Demonstrates strong work ethics and a “can do” attitude.
• Demonstrates competence in data analysis and report writing.
• Good verbal and written communication skills.
• Good interpersonal skills: ability to work as an effective team member.
• Working knowledge of PC software, preferably Word and Excel.
• Embraces and leverages diversity of culture and thought.

Works in a laboratory environment. Is required to lift up to 20 lbs. May be required to sit or stand for long periods of time while performing duties. Ability to work safely with hazardous chemicals and infectious agents. Willingness to work overtime and flexible schedule as needed is a plus.