Qaulity Systems Engineer I - Cambridge, Massachusetts | CareerCircle
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Qaulity Systems Engineer I

Actalent

02/22/2022

Posting ID: JP-002664392

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Cambridge, Massachusetts
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Description:

Core Responsibilities:

  • Support revision of procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies.
  • Apply and maintain quality standards and procedures for quality systems.
  • Review executed cGMP documents and participate in the implementation of systems for the acquisition, processing and storage of cGMP information.
  • Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).

Top Skills Details:

  • risk management, device history, or change management

Additional Skills & Qualifications:

  • Bachelor’s degree or equivalent with 1+ years of cGMP experience.
  • Prior experience working in a Quality/Compliance role within the pharmaceutical or medical device industry.
  • Experience writing and reviewing technical cGMP documents.
  • Experience with an electronic Quality/Document Management System.
  • Strong written and verbal communication.
  • Experience operating in an environment with strict timelines.

Change Control/Design Control:

  • Support the process of change control approval from evaluation of an initial proposal through approval, implementation, closure and effectiveness review.
  • Provide QA support of change controls to ensure that they meet the requirements of standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a quality management system electronic workflow.
  • Apply and interpret procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects.
  • Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes.
  • Assist in the management of the Design Control program, updates to Design History Files, and participate as a Quality representative in the design review process.
  • Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.

Risk Management:

  • Assist with driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
  • Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations.

Experience Level:

Entry 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.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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