C&Q Specialist

Posted 8 Days Ago
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Gurabo, PRI
In-Office
2-3 Annually
Junior
Pharmaceutical
The Role
The C&Q Specialist will support commissioning, qualification, and validation activities, develop protocols, and ensure compliance with regulations while maintaining safety standards.
Summary Generated by Built In

For C&Q services in the Business Operations area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Science, or Engineering field with at least 2 years of proven experience or BS in Business Administration field with at least 3 years of proven experience in commissioning and qualification processes, protocolsgeneration and execution.
  • Bilingual (Spanish and English.)
  • Shift: Administrative and according to business needs. 
  • Experience in:
    • Execute commissioning and qualification activities in the field
    • Generate protocols and technical documents following current industry and  requirements and regulations
    • Execute commissioning and qualification activities in the field
    • Report deviations during tests, propose corrective actions, and participate in implementation and verification of corrections.
    • Plan and coordinate resources, measurement/calibration equipment and tooling needed for tests.

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 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 take on this new challenge?

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

  • Support the planning and executing of commissioning, qualification, and validation (CQV) activities.
  • Develop qualification protocols
  • Support and influence effectively to ensure all necessary Commissioning, Qualification, and Validation (CQV) activities are completed on time and according to the validation program.
  • Developing validation status reports.
  •  Participate in and support Factory acceptance test (FAT) and Site Acceptance tests (SAT) of new equipment.
  • Record results legibly and verifiably, following data integrity principes (ALCOA) where applicable.
  • Report deviations during tests, propose corrective actions, and participate in implementation and verification of corrections.
  • Plan and coordinate resources, measurement/calibration equipment and tooling needed for tests.
  • Comply with site safety rules, permits and policies while on site.
 

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?

Skills Required

  • Bachelor's Degree in Science, Engineering, or Business Administration
  • At least 2 years of proven experience in commissioning and qualification processes
  • Bilingual (Spanish and English)
  • Experience with executing CQV activities in the field
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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