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Compliance Specialist (Change control/Change management)

  • Location: Massachusetts
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 07 August 2022
  • Referral: 211920@accuick.com

Job Description:

  • The Quality Product Compliance (QPC) Project Coordinator will support the execution of Quality Assurance activities that fall within the Global Quality Key Brands organization.

  • This includes support of marketing and post-marketing changes, global change management implementation planning, as well as supporting other key QPC initiatives and programs.

  • The QPC Project Coordinator will work collaboratively with QPC Management and QPC Project Managers and will also collaborate with the various brand teams and the global Quality organization to reach compliant solutions.

Major Duties and Responsibilities:

  • Advise change record authors on ensuring an integrated approach to change controls and related child actions, driving consistency across sub-teams, brands and sites, including external manufacturing sites.

  • Support the coordination and generation of Annual Product Quality Review (APQRs) Reports

  • Work closely with various brand teams and Global Quality organization to communicate specific timelines to team members to ensure on-time deliverables are completed.

  • Assist Quality Product Leads (QPLs) with management of Brand strategies to ensure consistency in product release and market supply.

  • Support continuous improvement projects to improve Quality Systems and processes, supporting the team with development and utilization of tools for providing standardized work and communications for group initiatives.

  • Perform other related duties and assignments, as required.

Education:

  • Bachelors degree or equivalent experience

  • 3-5 years of experience in a Quality role within a cGMP biopharmaceutical manufacturing environment.

Experience/Knowledge:

  • Demonstrated understanding of quality processes around post-approval change management.

  • Working knowledge of specification/method and change control quality systems.

  • Excellent technical writing skills with ability to edit materials to ensure accuracy, clarity, and consistency.

  • Ability to work collaboratively with cross-functional teams. Experience with working with/or supporting a matrix environment.

  • Strong interpersonal, verbal, and written communication.

  • Proven track record of successful management of projects and ability to meet critical timelines.

Skills/Competencies:

  • Expertise with MS Office, Word, Excel, Sharepoint, MS Teams, Change Control and document management systems

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613