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Quality Assurance Specialist

Location
Congers, New York
Job Type
Permanent
Posted
22 Sep 2022

Description:

This person evaluates, designs, executes, measures, and monitors quality and regulatory processes. Work to ensure that quality and regulatory processes inputs and outcomes are in harmony with the organization's goals, production environment, regulatory authorities, and any other body of compliance. They work collaboratively across all departments, including internal and external audits of the Quality Management System processes. Also responsible for coordinating quality activities to ensure that quality, regulatory and other departments are working as effectively as possible. QA/RA Specialist is responsible for the creation, and maintenance of documents in the QMS and document control system to ensure accuracy and compliance.

  • Work with all departments to ensure quality and regulatory compliance is well maintained in all processes, documents, procedures, and forms.
  • Review and approval of documents via the document control software.
  • Maintain a broad understanding of new and existing regulations that may impact the organization's processes and/or products.
  • Work with quality control and quality assurance at the contract manufacturing organization during manufacturing, complaint investigation and maintenance of production records.
  • Provide quality and regulatory support to any department that will require assistance.
  • Fully participate in all processes to eventually master and understand the organization's products, QMS structure, and processes.
  • Preparing for, facilitating, and executing internal and third-party audits as necessary.
  • Work with the manufacturing plant to support, and ensure the products requirements and specifications are met.
  • Work with customers to meet their requests and needs.
  • Maintain the organization QMS compliance to ISO 9001, ISO 13485, FDA, and other regulatory bodies/requirements.
  • Responsible for collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies.
  • Develop and/or track quality metrics.
  • Assist management as required.

Skills:

Quality assurance, regulatory affairs, document control, fda submissions, iso 9001, iso 13485

Additional Skills & Qualifications:

  • Bachelor's degree in quality field, clinical or life science (biology or chemistry) or equivalent experience.
  • Experience and understanding of quality management systems; their structure and processes.
  • Four plus years in ISO 9001 and ISO 13485 standards, regulations, and related industries/fields.
  • 3 + years of experience in planning, coordination, and management of regulatory documentation activities.
  • 4 + years of experience in manufactory processes, medical devices, technical, clinical and GMP practices.
  • 4 + years of experience in quality assurance and related activities.
  • Experience in technology and manufacturing transfer will be a plus.
  • Experience in global regulations of chemicals will be plus.
  • Ability to write SOP, WIs, quality and regulatory reports

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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Details

  • Job Reference: 718925039-2
  • Date Posted: 22 September 2022
  • Recruiter: Actalent
  • Location: Congers, New York
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent