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Compliance Specialist

  • Location: Massachusetts
  • Job Type:Contract

Posted 10 days ago

  • Expiry Date: 17 December 2022
  • Referral: 219797@accuick.com

Job Description:

  • 50% Remote (Note: Person MUST be available to report to the Client Devens, MA Site upon hire. Out of state candidates and/or remote candidates will not be considered for this position).

MUST HAVs:

  • * Experience in a cGMP biopharmaceutical manufacturing environment with demonstrated knowledge of biotechnology processes (e.g.: drug substance/API, drug product, etc.)

  • * Knowledge of FDA and EU regulatory requirements.

  • * Experience with quality management systems (ie: change controls, deviations etc.)

Principle Objective of Position:

  • 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:

  • 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:

  • Bachelor's degree or equivalent experience.

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

Experience/Knowledge:

  • Working knowledge of quality management 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

  • ****50% Remote (Note: Person MUST be available to report to the Devens, MA Site upon hire. Out of state candidates and/or remote candidates will not be considered for this position)

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.