Quality Specialist Job In Phoenix, Arizona, Axelon Services Corporation

Published 2022-08-08
Expires 2022-09-08
ID #1119184170
Quality Specialist Job In Phoenix, Arizona, Axelon Services Corporation
United States, Arizona, Phoenix,
Published August 8, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Quality specialist

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100% ONSITE role


The Quality Specialist is responsible for the technical aspects of quality

assurance for material suppliers and vendors used to manufacture, package and test commercial

drug products in accordance with cGMP policies, standards, and procedures. The incumbent will be

responsible for the review and approval activities related to various suppliers including raw material,

consumable, external labs, transportation suppliers, etc. used for the manufacture, package and

testing of drug products. Additional responsibilities include but are not limited to, providing quality

support to stakeholders and SMEs, reviewing/approving product related GMP documents, releasing

Incoming materials for use in production, and authoring supplier quality system documents.

Required Competencies: Knowledge, Skills, and Abilities:

" Basic knowledge of cGMP, ICH, JP, USP and EP

" Ability to multi-task and be flexible

" Strong teamwork skills

" Ability to complete routine tasks with moderate direction; work is self-directed; consults

manager for advice on complex issues

" Ability to directly contribute to the team performance and team results

" Ability to follow established procedures and performs work as assigned

" Ability to follow directions and communicate effectively with peers, team and supervisor

" Ability to leverage internal relationships within function to achieve objectives with guidance

" Able to recognize conflict and notify management

" Basic writing skills, able to follow technical reports

Duties and Responsibilities:

Supports all processes, documents, and activities related to incoming materials and external suppliers.

QA support for the Supply Management, QC Incoming, and Incoming Materials Warehouse departments.

Responsibilities include:

" QA review and approval of deviations and CAPAs

" QA review and approval of Change Controls (e.g., DCCs, CCRs) to ensure the proposed

changes are justified, supported by data and have been appropriately validated/qualified

where applicable

" QA review and approval of all materials for use in commercial production

" Supplier Alert management

" Material review, disposition, and execution of MERs

" QA review and approval of protocols, documents (specifications), compendial, and QRM

" Quality Agreement (QTA) management

" Periodic review of department processes

" Provide support for supplier audits and assessment of suppliers

" Support complaint sample/reserve sample inspection

" Adopts and applies QRM principles to make sound quality decisions

" Interfaces with all other quality groups within the company on quality systems issues

" Works with other departments to ensure compliance with and understanding of cGMPs,

SOPs, and policies

" Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure

issues are resolved in a compliant manner

" Serves as the chief QA point of contact for assigned projects/initiatives

" Consults management for advice on complex issues; confident in making decisions for minor


" Proposes solutions for issues and works with management to resolve

" Performs all other tasks as assigned

Education and Experience:

" High school diploma or equivalent required

" Bachelor s degree preferred

" Minimum of 2 years of relevant work experience required, preferably in quality assurance/quality control

" An equivalent combination of education, experience and training may substitute


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    Axelon Services Corporation
    Registered on October 7, 2017


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    Arizona ( (listen); Navajo: Hoozdo Hahoodzo Navajo pronunciation: [xòːztò xɑ̀xòːtsò]; O'odham: Alĭ ṣonak Uto-Aztecan pronunciation: [ˡaɺi ˡʂonak]) is a state in the southwestern region of the United States. It is also part of the Western and the Mountain states. It is the 6th largest and the 14th most populous of the 50 states. Its capital and largest city is Phoenix. Arizona shares the Four Corners region with Utah, Colorado, and New Mexico; its other neighboring states are Nevada and California to the west and the Mexican states of Sonora and Baja California to the south and southwest. Arizona is the 48th state and last of the contiguous states to be admitted to the Union, achieving statehood on February 14, 1912. Historically part of the territory of Alta California in New Spain, it became part of independent Mexico in 1821. After being defeated in the Mexican–American War, Mexico ceded much of this territory to the United States in 1848. The southernmost portion of the state was acquired in 1853 through the Gadsden Purchase. Southern Arizona is known for its desert climate, with very hot summers and mild winters. Northern Arizona features forests of pine, Douglas fir, and spruce trees; the Colorado Plateau; mountain ranges (such as the San Francisco Mountains); as well as large, deep canyons, with much more moderate summer temperatures and significant winter snowfalls. There are ski resorts in the areas of Flagstaff, Alpine, and Tucson. In addition to the internationally known Grand Canyon National Park, which is one of the world's seven natural wonders, there are several national forests, national parks, and national monuments. About one-quarter of the state is made up of Indian reservations that serve as the home of 27 federally recognized Native American tribes, including the Navajo Nation, the largest in the state and the United States, with more than 300,000 citizens. Although federal law gave all Native Americans the right to vote in 1924, Arizona excluded those living on reservations in the state from voting until the state Supreme Court ruled in favor of Native American plaintiffs in Trujillo v. Garley (1948).

    Source: https://en.wikipedia.org/