Lead, Production- 3rd shift

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  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.
  

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  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

Responsible for filling, lyophilization and labeling functions of the Production Filling team. Operates and troubleshoots production equipment. Manufactures product per documented manufacturing instructions. Maintains records to comply with GMP's, SOP's, quality system requirements, and other regulatory requirements. Performs in-process testing to assure batches meet specifications. Works on complex assignments in a dynamic and fast paced environment where independent action and initiative are required to resolve problems. Leads and develops Production Specialists. Supports all applicable regulations including but not limited to FDA and ISO requirements.

Key Responsibilities and Duties

• Competent to complete cGMP filling documentation.
• Clean, prepare, and set-up production equipment for processing operations.
• Operate production equipment in clean room and non-clean room environment.
• Perform in-process quality checks for specific quality attributes (fill check, torque check and label check, etc.). Inspect product for defects and conformance to quality standards.
• Clean work area and production equipment. Decontaminate work surfaces in accordance with defined procedures.
• Follow Diasorin's established procedures for the safe handling and disposal of hazardous and infectious material.
• Be aware of and understand the hazards specific to your work area and follow appropriate safety precautions necessary to control them.
• Utilize SAP system for performing material transactions, work order completion, quantity reconciliation, and cycle counts.
• Assist in trouble shooting routine production equipment and processes and notify engineering and supervisor of issues.
• Operate and train others on running lyophilizers and the Manufacturing forms that come with it.
• Actively participate in process improvement projects.
• Train new employees, monitor and provide feedback to employees and management.
• Perform in-process testing of product with ability to interpret results and perform any required adjustments to applicable equipment.
• Create and execute Production schedule per plan. Monitor progress of outstanding work orders and expedite as required to meet scheduled due date.
• Close work orders and review manufacturing specification for accuracy and completeness.
• Identify non-conformances and initiate required documentation.
• Support leadership with reviewing and revising manufacturing specifications, department specific procedures, and/or create new documents as required.
• Recommend to Supervisor/Manager product or process improvements which will enhance product or business.
• Review and revise existing documents. Recognize deficiencies and create new documents as required.
• Contribute to Lean manufacturing and continuous improvement projects as needed.
• Understand, comply, support, and enforce all policies and procedures.
• Support the design and execution of validation protocols and experiments to enhance product, resolve product issue, and manufacturing process.
• Demonstrate competency in Diasorin's safety policies and procedures and be aware of the hazards specific to the work area.

Additional Responsibilities and Duties

• Assist in special projects.
• Assist in other production areas/departments as needed.
• As needed, assist with writing reports - Investigations, Risk Assessments, Validations, Quality Plans, etc.
• Perform other duties as assigned.

Education, Experience, and Qualifications

• H.S. Diploma or equivalent required, Associates degree preferred.
• 4+ years' experience in manufacturing experience in related field. Experience in biotechnology / medical device fields required.
• 2+ years' experience Management experience is preferred
• Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Can Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Receives no instructions on routine work, general instructions on new assignments
• Good interpersonal and verbal communication skills
• Ability to read, analyze, and interpret general, technical procedures, or governmental regulations. Ability to write reports. Ability to effectively present information and respond to questions from groups of supervisors, engineers, or managers
• Ability to add, subtract, multiply, and divide. Ability to round numbers to the nearest whole number, tenths, hundredths, or thousandths. Knowledge of metric system with ability to convert units - weight (milligram, gram, kilogram, etc.), volume (milliliter, liter, etc.), and distance (centimeter, millimeter, meter, etc.)
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to read, write and speak in English.
• Ability to use basic math functions in documentation process.
• Experience working with Microsoft Office programs.
• Attention to detail.
• Independently operate all machinery as assigned.
• Experience working with automated equipment.
• Good interpersonal and verbal communication skills.
• Ability to solve practical problems.
• Mechanical aptitude and troubleshooting skills.

What we offer

Salary Range

The hourly range for this position is $27.22-$34.50 Hourly. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.