Quality Assurance Inspector II

Takeda•Van Nuys, CA

3d•$22 - $34•Onsite

About The Position

About the role: As a Quality Assurance Inspector II, you are responsible for inspection activities for all chemicals and components used in the manufacturing process. You will ensure raw materials meet specifications and reject those that fail to meet quality expectations. How you will contribute: Perform sampling of chemicals in a classified room using appropriate gowning and safety measures. Perform routine cleaning of classified room used for chemical sampling. Conduct physical analysis on incoming chemicals as required per material’s specification. Responsible for the quarantine and/or destruction of nonconforming materials. Responsible for inspection and release of production materials, components, and chemicals to manufacturing facility, including intermediate paste shipment verification, while ensuring adherence to SOPs and Material Specifications for accuracy and compliance. Responsible for sampling raw materials in an ISO classified environment, including preparation and shipment of samples to the required laboratories. Responsible for performing room cleaning and environmental monitoring in the ISO classified rooms. Perform tagging and untagging of non-conforming material in a timely manner, as well as inventory material in non-conforming areas; and coordinating non-conforming material returns to the supplier. Responsible for coordinating with third party bonded destroyers for the destruction of non-conforming material. Responsible for appropriate storage and disposal of retention and reference samples. Operate and proactively maintain laboratory and warehouse equipment through routine maintenance and/or calibrations. Ensure that equipment maintenance is properly documented in a timely manner. Maintain data integrity and ensure compliance with company SOP’s, Material Specifications, FDA, and cGMP regulations. Operate powered industrial equipment for material handling. Assist in internal self-inspections and external audits by collecting documents as assigned by management. Initiate Deviations and Lab Investigations, as needed, in a timely manner. Support execution of validations for laboratory and/or inspection equipment, laboratory methods and/or facility projects. May perform other duties as assigned by management. May provide training to others as assigned. Be able to support departmental / plant goals.

Requirements

High school diploma or GED.
2+ years of related experience or AA (or equivalent) or higher with no prior experience required.
Familiar with cGMP and FDA requirements.
Be able to have great attention to details is necessary.
Ability to operate in a dynamic, high-paced, cross-functional environment.
Be able to handle multiple tasks concurrently.
Have strong organizational skills and the ability to follow-up on tasks.
Have effective verbal and written communication skill.
Be able to escalate issues affecting material’s quality in a timely manner.
Have general computer knowledge.
Have intermediate knowledge of laboratory and inspection tools, and warehouse equipment, as well as chemical handling.
Have general knowledge of biotech manufacturing theories and processes.

Nice To Haves

Have knowledge of Good Data and Documentation Practices (GDDP), current Good Manufacturing Practices (cGMP), and Environmental, Health and Safety (EHS) requirements preferred.

Responsibilities

Perform sampling of chemicals in a classified room using appropriate gowning and safety measures.
Perform routine cleaning of classified room used for chemical sampling.
Conduct physical analysis on incoming chemicals as required per material’s specification.
Responsible for the quarantine and/or destruction of nonconforming materials.
Responsible for inspection and release of production materials, components, and chemicals to manufacturing facility, including intermediate paste shipment verification, while ensuring adherence to SOPs and Material Specifications for accuracy and compliance.
Responsible for sampling raw materials in an ISO classified environment, including preparation and shipment of samples to the required laboratories.
Responsible for performing room cleaning and environmental monitoring in the ISO classified rooms.
Perform tagging and untagging of non-conforming material in a timely manner, as well as inventory material in non-conforming areas; and coordinating non-conforming material returns to the supplier.
Responsible for coordinating with third party bonded destroyers for the destruction of non-conforming material.
Responsible for appropriate storage and disposal of retention and reference samples.
Operate and proactively maintain laboratory and warehouse equipment through routine maintenance and/or calibrations.
Ensure that equipment maintenance is properly documented in a timely manner.
Maintain data integrity and ensure compliance with company SOP’s, Material Specifications, FDA, and cGMP regulations.
Operate powered industrial equipment for material handling.
Assist in internal self-inspections and external audits by collecting documents as assigned by management.
Initiate Deviations and Lab Investigations, as needed, in a timely manner.
Support execution of validations for laboratory and/or inspection equipment, laboratory methods and/or facility projects.
May perform other duties as assigned by management.
May provide training to others as assigned.
Be able to support departmental / plant goals.

Benefits

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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