Manufacturing Associate II, Reagents

Overview

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we develop innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made possible through ongoing investments in research, positions us as the Diagnostics Specialist."

Diasorin is a place where diverse, inclusive culture and global collaboration drive healthcare solutions. We are seeking motivated individuals who are ready to embrace new challenges and contribute to advancing diagnostics.

The Manufacturing Associate II, Reagents will be responsible for delivering manufacturing requirements against the production schedule within a focused manufacturing operation and/or product segment. The role may include alternate shifts and participation in manufacturing processes to support new product design transfer, stability programs, process development, equipment validations, process validations, investigations, and resolution of product/process issues. Responsibilities include monitoring and maintaining calibration of Manufacturing measuring and monitoring devices, maintaining the integrity of work areas, updating work instructions and standard operating procedures, and delivering associate change control.

This position will assist with the training of new Manufacturing Associates and will have frequent intra-department and inter-department interaction.

• Deliver manufacturing requirements and attainment of production schedule for standard inventory, build-to-order, and contract manufacturing market products.
• Deliver manufacturing requirements for qualification/processing of incoming materials, production intermediates, and stability samples.
• Complete manufacturing sections of process documentation and related business system transactions in a timely and accurate manner.
• Complete inventory cycle counts in a timely and accurate manner.
• Document non-conformances and participate in Material Review Board.
• Support design transfer and integration of new products and processes.
• Support process development and process improvements.
• Participate in the writing and execution of equipment and process validations.
• Assist in investigations and resolution of findings impacting the Reagent Manufacturing Organization identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation.
• Deliver timely maintenance and calibration of assigned manufacturing measuring and monitoring devices.
• Monitor select non-inventory supplies, maintain focused supplies, and generate purchase requisitions as needed.
• Maintain cleanliness and integrity of manufacturing laboratory and storage areas.
• Participate in department and interdepartmental training; maintain current and effective training to standard operating procedures, work instructions, and applicable changes affecting the Reagent Manufacturing.
• Assist in establishing annual performance goals; fulfill performance goals.
• Maintain effective and professional multi-level organizational interfaces.
• Maintain personal compliance and support departmental compliance with the Quality System.
• Adhere to safety, disposal, and gowning requirements.
• Update work instructions and standard operating procedures as required.
• Perform change control as required to support change requirements including Engineering Change Orders, Document Change Control, and Deviations.
• Assist in executing projects targeting efficiency, cost reduction, and quality improvements within the scope of Bioassay manufacturing processes.
• Support investigations and resolution of findings identified through audits, non-conformances, key performance indicator trends, corrective/preventive actions, or customer complaints escalation.
• Participate in task-specific training of new Reagent Manufacturing Associates.
• Other duties as assigned.

• Associate's Degree in Chemistry, Life Sciences, Biotechnology, or Medical Technology related field required
• Bachelor's Degree in Chemistry, Life Science, Biotechnology, or Medical Technology related field preferred
• 3+ years of relevant experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology industry required
• 1+ years of relevant experience in an FDA regulated and/or ISO certified organization preferred

• Standing - Frequently
• Stooping - Frequently
• Bending - Frequently
• Climbing - Occasionally
• Sitting - Occasionally
• Kneeling - Occasionally
• Lifting of at least 40lbs - Occasionally

The hourly posting for this position is $26.00-$32.00 hourly. The salary range for this role represents factors considered in hiring decisions, including education, skills, work experience, and certifications. Diasorin offers a comprehensive rewards package focused on…