Sr. Specialist QA

Posted 21 Days Ago
Be an Early Applicant
Juncos
1-3 Years Experience
Pharmaceutical
The Role
In this role, you will act as a technical specialist in support of Quality Assurance programs in the Packaging area of the Pharmaceutical or Medical Device industry. Responsibilities include reviewing and approving product MP's, process validation protocols, leading investigations, and representing Quality on incident triage and NPI teams.
Summary Generated by Built In

For Quality Services services in the Packaging area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s degree in Business Administration, Material Management, Science or Engineering with six (6) years of directly related experience in the Pharmaceutical or Medical Device industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Shift: Administrative and according to business needs.
  • Experience in:
    • Equipment qualification and computer systems qualification. 

The Personality Part:

  • If Quality is your middle name, keep reading! We’re looking for a passionate QA who likes to finish what they started and is confident in their ability to succeed. Sprinkle on a love of the scientific method, teamwork and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!

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

  • In support of Quality Assurance program acts as the technical specialist.
  • Review and approve product MP’s.
  • Approve process validation protocols and reports for mfg. Processes.
  • Represent Quality on incident triage team.
  • Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.

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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