Overview
Quality Assurance Specialist I Jobs in Santa Monica, CA at Kite Pharma
Description:
Basic Purpose and Function:
The Quality Assurance Inspector (QAI) will assist with the development, review, and implementation of FMSNA Quality Management System (QMS) policies, procedures, plans, and work instructions. This role is responsible for the communication of QMS requirements to all FMSNA staff, customers, and regulatory bodies and reports any deficiencies and proposed corrective actions to the QA Manager. The QAI provides input on quality metrics as determined by product test results, aides all departments in root cause analysis and corrective actions and ensures both the incoming and outgoing products conform to both internal and customer requirements and standards.
Major Responsibility (Functions/Duties):
Submits and reports Objective Quality Evidence (OQE) within 24 hours.
Performs and administers all nondestructive testing as required by the current procedures.
Maintains the highest level of safety awareness with respects to the use of SNT-TC-1A, state and local regulations and OSHA regulations.
Participates in audits as required to maintain all NDT practices, equipment, and licensing.
Arranges for and monitors non-destructive testing vendors required at FMSNA.
Maintains qualifications related to all nondestructive testing methods, and continually updates qualifications as deemed necessary by changing programs at FMSNA and changes to the regulatory guidelines.
Maintains all nondestructive testing equipment.
Develops and administers non-destructive testing training for other FMSNA employees, as necessary.
Participates in root cause analysis involving weld metal and base metal defects and discontinuities.
Inspects specified areas to ensure the presence of fire prevention equipment, safety equipment, or first-aid supplies.
Must have the knowledge needed to conduct job hazard analysis.
Produces Product Non-Conforming Reports (NCRs) for incoming non-conforming parts and enters data into the Product Non-Conforming log. Communicates items to the QA Manager for further resolution.
Performs spot checks.
Creates and maintains TIP and RRs in accordance with NSI 009-04.
Responsible for internal QMS audits.
Requirements:
Skills & Qualifications:
Identifies and resolves problems in a timely manner; Gathers and analyzes information; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Ability to read and analyze work specifications, work orders, schematics, blueprints, contracts, and other technical publications.
Ability to effectively present information and respond to questions from managers, clients, customers, and the general public.
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.
Working knowledge of Project Management software; MS Word and MS Excel. Experience in working with Microsoft Office preferred.
Ability to use various inspection equipment [calipers, micrometers, rulers, deep mics, bore gages, etc.]
Proven knowledge of quality control inspections and checkpoint notifications.
Knowledge of inspecting materials, parts, and products at different stages of production. Records observations and may make recommendations for improving processes.
Familiarity with standard concepts, practices, and procedures within the shipbuilding and engineering field.
Ability to read and interpret Occupational Safety and Health Administration (OSHA) Regulations, Naval Sea Systems (NAVSEA) Standard Items, and State and Local regulations.
Certified Lead Auditor or Internal Auditor.
Education and Experience:
Associate degree from an accredited junior or technical college in a related field, or a minimum of five (5) years’ experience in related field.
Ability to achieve Level II Qualification for Nondestructive testing (NDT) and interpretation in the Radiography Testing (RT), Liquid Penetrant Testing (PT), Ultrasound Testing (UT), Magnetic Particle Testing (MT) and Visual Testing (VT) methods in accordance with ASNT, SNT-TC-1A.
Three (3) to five (5) years of Safety experience preferred.
Level III Quality Inspection Certificate or Level II with working knowledge/prior experience with NDT (MT, PT, VT, UT and RT)
Experience with Flushing, Cofferdam, and 5XXX Aluminum Process Control Procedure requirements.
Experience with creating Test and Inspection Plans (TIPs) and Required Reports (RR) based on NAVSEA Standard Item 009-04 from Awarded Contracts. Experience with uploading TIPs and RRs to Navy Maintenance Database (NMD).
Experience with Joint Fleet Maintenance Manual (JFMM) Level One Control packages and material, and (Maintenance and Material Management (JFMM 3M) Manual Program Scheduling Software (SKED), MRC (Maintenance Requirement Card), and Maintenance Index Page (MIP).
Experienced with ISO 9001:2015 QMS, Naval Sea Systems Command (NAVSEA), American Bureau of Shipping (ABS), Untied States Coast Guard (USCG), and commercial standards.
Physical Requirements:
While performing the duties of this job, the employee is frequently required to sit, stand and walk/climb; use hands to handle materials or equipment; reach with hands and arms; stoop and kneel; and talk or hear.
Must be able to occasionally lift and/or move up to 50 pounds.
Must be able to work extended hours and alternate shifts.
Must be able to work in industrial area at times. This may subject the employee to moving equipment, elements, and extreme conditions.
Must be able to work in office environment part of the day to document inspections and complete records
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Title: Quality Assurance Specialist I
Company: Kite Pharma
Location: Santa Monica, CA
