Sr. Quality Systems Specialist - 013

Posted 18 Days Ago
Be an Early Applicant
Juncos
1-3 Years Experience
Pharmaceutical
The Role
Provides oversight for quality programs, systems, processes, and procedures in the Pharmaceutical & Medical Devices Industry. Ensures compliance with policies, regulations, and guidelines. Coordinates audits, inspections, and legal requests. Facilitates global quality assurance standards for a service provider company.
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 Sciences and Four (4) 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.
    • Trackwise application.
    • Investigation and Root Cause Analysis. 
    • GMP and GDP Regulations.

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?

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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