Production Lead Technician Job at Diasorin (Cypress)

Job Description

Responsible for manufacturing and assembly of clinical and commercial products. 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 manufacturing technicians. Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and CMD/CAS requirements.

Job Responsibility

Manufacture of subassemblies, components, and/or kits per documented methods
In-process testing of product with ability to interpret results and perform any required adjustments to product
Execute validation protocols and/or experiments
Ability to perform investigation to identify potential root cause of an issue
Ability to identify and implement CAPA (Corrective Action and Preventative Action)
Understand, comply, support, and enforce FDA and ISO regulatory requirements
Understand, comply, support, and enforce all policies and procedures
Lab maintenance per documented cleaning requirements
Inventory maintenance, replenish raw materials and supplies as required
Proper storage of raw materials, subassemblies, components, and kits
Equipment operation and maintenance per documented procedures, calibrate as required
Maintain product identification and traceability per Standard Operating Procedures (SOP)
Record required data on documents in accordance with GDP (Good Documentation Procedures) and SOP
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
Able to recognize deficiencies and create new documents as required
Inventory control – identify critical raw materials and establish and/or monitor a system to maintain control
Able to support the design and execution of validation protocols and experiments to enhance product, resolve product issue, and manufacturing process
Contribute to lean manufacturing and continuous improvement projects as needed
Close work orders and review manufacturing specification for accuracy and completeness
Train new employees, monitor and provide feedback to employee and management as required
Create and execute Production schedule per plan
Monitor progress of outstanding work orders and expedite as required to meet scheduled due date
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
Responsible for performing assigned tasks in accordance with the company’s quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual
Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies
Lead a team of employees within a given shift or unit
Also responsible for the overall direction, coordination, and evaluation of this unit
Carries out lead responsibilities in accordance with the organization’s policies and applicable laws
Responsibilities include performing daily work on the line, training employees
planning, assigning, and directing work
assessing team performance
making sure the team meets daily goal, and stays within cycle count
and addressing complaints and resolving problems
Responsible for enforcing all EHS policies in their span of control
Perform other duties as assigned

Requirements

Requires High School Degree or higher
Experience working on complex machinery as a Sr. Production Technician or equivalent is preferred
Analytically works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
Exercises 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
Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus
Ability to detect slight differences between products under magnification

What we offer

Health benefits
Retirement and financial wellbeing
Time off programs
Wellbeing support and perks
Annual incentive program

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Production Lead Technician

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