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Provide technical and planning leadership to the Production Filling team to ensure that the primary filling, lyophilization and labeling functions are performed according to company and customer specifications.
Job Responsibility:
Provide technical and planning leadership to the Production Filling team to ensure that the primary filling, lyophilization and labeling functions are performed according to company and customer specifications
Provide technical leadership especially related to product filling / processing / labeling
Review and update manufacturing documents for accuracy and completeness
Develop documents for use in manufacturing products as new technological information becomes available
Identify areas for process and process improvements and develop plans and strategies to achieve these improvements
Act as a major resource in areas of expertise
Provide training and support to employees
Develop minimum competences within the group
Lead training within the group
Participate in the development and delivery of internal training programs
Formally and informally lead training of others
Develop leadership competencies and foster an environment
Promote open channels of communication
Actively participate in team meetings
Actively facilitate in sharing information across the organization
Promote through interactions an environment that supports trusting relationships and ethical leadership
Select, train, evaluate and develop employees
Conduct coaching sessions
Prepare and conduct the performance assessment
Provide training and development to employees
Strategically identify characteristics and skill sets needed in future staff additions
Recruit and select employees for open positions
Establish and communicate responsibilities and expectations
Participate with the team manager in the financial planning process
Educate group leaders and team members
Monitor variable usage and scrap
Work with the operations groups
Perform work in a safe manner
Set a good safety example
Follow DiaSorin’s established procedures for the safe handling and disposal of chemicals, radioactive and infectious material
Consistently participate in DiaSorin’s safety training programs
Be aware of and understand the hazards specific to the work area
Ensure that direct reports are acting in a manner that consistently demonstrates compliance
Actively participate in and support efforts to improve the safety of the workplace
Understand and utilize documentation protocols
Understand the appropriate Universal Operating Procedures (UOPs)
Review, understand, and accurately complete in a timely fashion, documents such as procedures, forms, worksheets, and notebooks
Route, handle and/or store completed documentation
Initiate Engineering Change Orders (ECO), Nonconformance Reports (NC) and Deviations
Follow DiaSorin's established compliance procedures
Recommend, develop and implement plans
Develop systems and processes
Work across departments/groups
Proactively maximize resources
Perform and document calibration and preventative maintenance
Perform necessary calibrations on laboratory equipment
Maintain records of preventative maintenance
Perform minor repairs on equipment
Contact outside vendors to conduct major repairs and other preventative maintenance
Requirements:
H.S. Diploma or equivalent education required
Associates or Bachelor’s Degree preferred
2+ Years serving in a supervisory/lead role required
5+ Years of production experience with demonstrated increase in responsibilities required
Supervisory experience required
Experience with OSHA Regulations required
Cleanroom experience required
Service in a life science/medical device field with lyophilization knowledge desirable
Bottling and labeling machines
GMP and ISO regulations
Immunoassays and reagent handling techniques
LEAN methodologies
Production scheduling
Budgeting processes, including capital equipment justification
Employment law
Skilled in the use of Microsoft Office products
Familiarity with Google Suite
Demonstrated decision making and critical thinking abilities
Strong multi-tasking capabilities
Ability to work and communicate effectively with a wide range of co-workers in a cooperative manner
Ability to delegate authority, work, and or autonomy of decision making to others to better distribute work activities or to develop staff
Ability to grasp complex concepts
Demonstrated ability to diagnose problems by separating essential from non-essential variables
Flexibility and willingness to adapt to a changing environment and work load
Excellent written and verbal communication skills
Skill at preparing written materials such as reports, presentations, and proposals
Nice to have:
Associates or Bachelor’s Degree preferred
Service in a life science/medical device field with lyophilization knowledge desirable