Production Lead Technician

diasorinsp•Cypress, CA

3d•$20 - $32•Onsite

About The Position

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.

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.

Nice To Haves

Experience working on complex machinery as a Sr. Production Technician or equivalent is preferred

Responsibilities

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. Documentation may include NCMR (Non-Conforming Material Report), deviation report, CAPA, investigation report, and/or risk assessments.
Support leadership with reviewing and revising manufacturing specifications, department specific procedures, and/or create new documents as required. Implement change via DCR (Document Change Request).
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. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
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.