JT616 - SPECIALIST MANUFACTURING

Juncos, Puerto Rico
Contracted
Biopharmaceutical
Experienced

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

  • Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
  • Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
  • May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
  • Lead and oversee operational excellence projects and transformation initiatives of medium to high complexity to support the continuous improvement of the ES RMD Quality Record Management.
  • Lead continuous improvement projects that deliver measurable gains in quality, efficiency, and alignment within Amgen. Apply the knowledge, skills, and tools of project management / Operational Excellence (OE) to ensure optimal project performance and continuous improvement initiatives.
  • Create, own, and maintain visual management tools and global processes that use digital capabilities, like Smartsheet, Tableau, Miro, and similar tools
  • Coordinate and facilitate cross-functional workshops that may be required by the initiatives, leveraging Miro.
  • Partner with internal and external cross-functional teams, manage related meetings, minutes, action items, escalations, and drive the decision-making process.
  • Project management of resource planning, generating and reporting metrics / Key Performance Indicators, and presentation materials for management reviews and governance meetings.
  • Responsible for building project plans and team assignments using Gantt charts, estimating project cost and adhering to budget, advising and supervising work efforts daily, identifying resource needs, performing business quality reviews, and appropriately escalating functional, quality, timeline, and cost issues.
  • Use project management processes, software, and methodologies to ensure projects are delivered on time, within budget, adhere to high-quality standards, and meet internal and external customer expectations.
  • Coordinate communication with all areas of the enterprise that impact the scope, budget, risk, and resources of the work being managed.
  • Develop and apply change management plans for the implementation of initiatives.
  • Manage and lead medium to sophisticated projects, comfortable with change and uncertainty.

Qualifications:

  • Bachelor Degree in any Engineering, typically Industrial Engineering is more suited for this role.
  • Experience in Software: Smartsheet, Miro, Tableau
  • Detailed technical understanding of bioprocessing unit operations.
  • Skilled in performance of GMP production operations.
  • Regulatory knowledge and interactions.
  • Basic project management skills.
  • Basic knowledge of control charting.
  • Skills in leading and managing cross-functional teams in diverse cultures and geographic locations, and conflict resolution with diplomacy.
  • Extensive knowledge and expertise in the use of project management methodologies and tools, resource management practices, and organizational change techniques.
  • Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook) with also strong analytical skills and knowledge of tools within Smartsheet, Tableau, Miro, and other software programs.
  • Demonstrated experience with building dashboards, forms, automation, etc, in Smartsheet.
  • Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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