• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Job Scope

The Manufacturing Associate II, Reagents will be responsible for:

• Delivering manufacturing requirements against production schedule within a focused manufacturing operation and/or product segment. Work schedule may include alternate shifts.
• Participating in manufacturing processes to support new product design transfer, stability program, process development, equipment alidations, process validations and investigations and resolution of product/process issues.
• Monitoring and performing maintenance and calibration of Manufacturing measuring and monitoring devices as well as maintaining the integrity of work areas.
• Updating work instructions and standard operating procedures as well as delivering associate change control. Training of new Manufacturing Associates
• Frequent intra-department interaction as well as frequent inter-department interfaces.
  

Key Duties and Responsibilities

• 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.
• Deliver timely and accurate completion of manufacturing sections of process documentation and related business system transactions.
• Deliver timely and accurate completion of inventory cycle counts.
• 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.
• Support 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 applicable departmental 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 facilitate 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 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.

Education, Experience and Qualifications

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

Standard Physical Demands

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

Travel Requirements

• 0% Travel not required

What we offer

Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.