Sr. Quality Systems Specialist - 132

Reposted 10 Days Ago
Be an Early Applicant
Juncos, PRI
In-Office
Senior level
Pharmaceutical
The Role
The role involves managing quality programs and ensuring compliance in the Pharmaceutical and Medical Devices industry, leading audits, and providing guidance on regulatory issues.
Summary Generated by Built In

For Engineer services in the Quality area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering and three (3) years of exposure within the Pharmaceutical & Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Excellent Communication skills, and Positive attitude. 
  • Shift: 1st Shift
  • Experience in: 
    • Process Validation and Computer Software Validation.
    • Technical writing knowledge
    • Organization and communication
    • Investigation and Root Cause Analysis. 

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)

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages.
  • Coordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally. 

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

Computer Software Validation
Process Validation
Root Cause Analysis
Technical Writing
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
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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