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Quality Assurance Specialist

Endeavor Consulting Group
Fort Washington, PA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Change Control Quality Assurance Specialist

The Change Control Quality Assurance Specialist will ensure compliance by coordinating Change Controls associated with supplier and raw materials changes to primary and secondary packaging, APIs, and excipients impacting company internal and external sites. The Change Control Quality Assurance Specialist will initiate EtQ system Change Control requests to be communicated to internal and external manufacturing, testing and packaging sites with input from Sourcing, Supplier Quality, Site Leaders, Quality, and other Subject Matter Experts (SMEs) as needed. The Change Control Quality Assurance Specialist will present Change Control Requests at Change Control Committee (CCC) Meetings and interface with the Change Control approvers to align wording, requirements and deliverables as needed to facilitate approval process.

As part of this role, the Change Control Quality Assurance Specialist will track/monitor Change Controls through their lifecycle. This includes, but is not limited to timely promotion & notification of change in status, regular updates to Change Control owners (Sourcing, Site Leaders, Quality & SMEs) on Change Controls and deliverable status, weekly monitoring and reporting of change control metrics including submissions, approvals and closures. This role will coordinate deliverables execution and documentation in Change Control as deliverables are received and ensure Change Controls are closed in a timely manner or initiate extensions when necessary if target closure date is not attainable. In some cases, the Change Control Quality Assurance Specialist will need to act as a project manager and facilitate team meetings to ensure that changes are implemented to meet business needs.


Requirements


  • A Bachelor's Degree is required. - A focus degree in Science or Engineering Technologies is preferred.
  • A minimum of 4 years experience in a GMP regulated environment (pharmaceutical etc.) is required.
  • A technical writing background is preferred.
  • Experience with pharmaceutical or consumer manufacturing (processing/packaging, etc.) is required.
  • Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred.
  • The ability to handle multiple, at times complex change controls at one time is required.
  • The ability to read, analyze and interpret common scientific and technical documents is required.
  • Project management, organizational skills and the ability to adapt to a fast-paced environment with changing priorities is preferred.
  • The ability to effectively present information and communicate clearly to all levels of management is required. The ability to work directly with internal and external manufacturing sites under limited supervision is preferred.
  • Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are preferred).
  • Previous experience working in cross functional matrix environment with an ability to influence without authority is required. Knowledge of six sigma, process improvement or lean is preferred.
  • Individual must demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple projects, prioritize and adapt to business needs, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills, problem-solving and Lean mindset.

Benefits

A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.

Endeavor Consulting Group

Address

Fort Washington, PA
USA

Industry

Technology

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