Sr. Specialist QA

Posted 4 Days Ago
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Juncos
Senior level
Pharmaceutical
The Role
Manage project management aspects including planning, implementation, monitoring, and ensure compliance with regulations. Requires strong communication and problem-solving skills in a pharmaceutical context.
Summary Generated by Built In

For Project Management services.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor of Science in Engineering and at least five (5) years of experience in Project Management within the Pharmaceutical Industry.
  • Shift: Administrative and according to business needs. 
  • Bilingual: English and Spanish (verbal/written). 
  • Experience in:
    • Change control processes and systems. 
    • Commercial product life cycle, manufacturing, product variations, and/or new product introduction.
    • Scheduling and coordination around production schedules.
    • Managing quality systems and/or managing deviations (non-conformances).

The Personality Part: 

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
  • Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
  • Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
  • Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
  • Maintain and track project budget(s).
  • Reconcile the use of resources for the projects.
  • Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
  • Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
  • Actively participate in directing the evolution and defining the role of the project
  • Ensure the project goals and objects are well understood by the various functional areas.
  • Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
  • Maintain the master project plan and schedule for assigned projects.
  • Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
  • Provide department management with project management support on an as needed basis as well as for special projects.
  • May manage and direct the activities of project support staff
  • Conduct annual performance reviews and provides career counseling and general guidance.
  • Identify or lead focus area projects within the overall function of project management or related projects. Generate periodic updates and prepare formal presentations for required forums.
  • Generate individual and more complex reports utilizing various resources.
  • Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
  • Ensure project work complies with practices, policies and standard operating procedures.
  • Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
  • Anticipate resource needs and communicate to management sponsors.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Top Skills

Budget Management
Change Control
Project Management
Quality Systems
Reporting Tools
Scheduling
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
On-site Workplace
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are We The Right Piece For You?
We are:

Experienced and knowledgeable in the Industry
Committed to Safety
Always compliant with FDA Regulations & Audits
Cost Effective
Proven successful track record
Over ten (10) years of experience

If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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