Quality Assurance Inspector II
Takeda Pharmaceuticals, Van Nuys, CA, United States
Quality Assurance Inspector II
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.
Your responsibilities include performing sampling of chemicals in a classified room using appropriate gowning and safety measures, routine cleaning of classified room used for chemical sampling, conducting physical analysis on incoming chemicals as required per material's specification, and responsible for the quarantine and/or destruction of nonconforming materials.
You will also be 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. Additionally, you will be responsible for sampling raw materials in an ISO classified environment, including preparation and shipment of samples to the required laboratories.
You will perform room cleaning and environmental monitoring in the ISO classified rooms, and 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.
You will be responsible for coordinating with third party bonded destroyers for the destruction of non-conforming material, and for appropriate storage and disposal of retention and reference samples. You will operate and proactively maintain laboratory and warehouse equipment through routine maintenance and/or calibrations, and ensure that equipment maintenance is properly documented in a timely manner.
You will 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, and support execution of validations for laboratory and/or inspection equipment, laboratory methods and/or facility projects.
You may perform other duties as assigned by management, provide training to others as assigned, and be able to support departmental / plant goals.
To qualify for this role, you should have a high school diploma or GED. 2+ years of related experience or AA (or equivalent) or higher with no prior experience required. You should be familiar with cGMP and FDA requirements, have great attention to details, ability to operate in a dynamic, high-paced, cross-functional environment, handle multiple tasks concurrently, have strong organizational skills and the ability to follow-up on tasks, effective verbal and written communication skill, ability to escalate issues affecting material's quality in a timely manner, general computer knowledge, intermediate knowledge of laboratory and inspection tools, and warehouse equipment, as well as chemical handling, and general knowledge of biotech manufacturing theories and processes.
You should also have knowledge of Good Data and Documentation Practices (GDDP), current Good Manufacturing Practices (cGMP), and Environmental, Health and Safety (EHS) requirements preferred.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. You may need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. You may work in a cold, wet environment. You may work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. You may work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. You must be able to lift, push, pull and carry up to 50 lbs. You must be able to operate warehouse machinery and equipment. In general, the position requires a combination of sedentary work, operating machinery, and equipment, and standing or walking to perform inspection and release. You will work in office and warehouse environment. You will work with or around moving equipment and machinery. You may be exposed to dust, gases, and fumes. The pace may be fast and job completion demands may be high. You must be able to work multiple shifts, including weekends. You may be required to travel for business reasons, e.g. training and meetings. 5% travel.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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.
Your responsibilities include performing sampling of chemicals in a classified room using appropriate gowning and safety measures, routine cleaning of classified room used for chemical sampling, conducting physical analysis on incoming chemicals as required per material's specification, and responsible for the quarantine and/or destruction of nonconforming materials.
You will also be 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. Additionally, you will be responsible for sampling raw materials in an ISO classified environment, including preparation and shipment of samples to the required laboratories.
You will perform room cleaning and environmental monitoring in the ISO classified rooms, and 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.
You will be responsible for coordinating with third party bonded destroyers for the destruction of non-conforming material, and for appropriate storage and disposal of retention and reference samples. You will operate and proactively maintain laboratory and warehouse equipment through routine maintenance and/or calibrations, and ensure that equipment maintenance is properly documented in a timely manner.
You will 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, and support execution of validations for laboratory and/or inspection equipment, laboratory methods and/or facility projects.
You may perform other duties as assigned by management, provide training to others as assigned, and be able to support departmental / plant goals.
To qualify for this role, you should have a high school diploma or GED. 2+ years of related experience or AA (or equivalent) or higher with no prior experience required. You should be familiar with cGMP and FDA requirements, have great attention to details, ability to operate in a dynamic, high-paced, cross-functional environment, handle multiple tasks concurrently, have strong organizational skills and the ability to follow-up on tasks, effective verbal and written communication skill, ability to escalate issues affecting material's quality in a timely manner, general computer knowledge, intermediate knowledge of laboratory and inspection tools, and warehouse equipment, as well as chemical handling, and general knowledge of biotech manufacturing theories and processes.
You should also have knowledge of Good Data and Documentation Practices (GDDP), current Good Manufacturing Practices (cGMP), and Environmental, Health and Safety (EHS) requirements preferred.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. You may need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. You may work in a cold, wet environment. You may work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. You may work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. You must be able to lift, push, pull and carry up to 50 lbs. You must be able to operate warehouse machinery and equipment. In general, the position requires a combination of sedentary work, operating machinery, and equipment, and standing or walking to perform inspection and release. You will work in office and warehouse environment. You will work with or around moving equipment and machinery. You may be exposed to dust, gases, and fumes. The pace may be fast and job completion demands may be high. You must be able to work multiple shifts, including weekends. You may be required to travel for business reasons, e.g. training and meetings. 5% travel.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.