Skip to Main Content

Quality Assurance Scientist

FITS LLC
00674, PR
  • Posted: over a month ago
  • Contractor
Job Description

For Quality services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor’s degree in Science (Chemistry, Biology or Microbiology) or Engineering and three (3) years of experience within the pharmaceutical industry. A minimum of one (1) year of experience in Quality Assurance responsibilities is required.
  • Shift: 1st shift (8:00am- 5:00pm)
  • Experience in:
    • Manufacturing operations of Oral Solid Dosage and Parenteral Products
    • Batch Record, Protocol and Investigation Review
    • CAPA, Change Control, Annual Product Review.
    • GMP, FDA, EU regulations
    • Computer systems: Microsoft Office, TrackWise and SAP

The Personality Part:

  • Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

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

  • Support manufacturing operations areas such as Compounding, Filling, preparation, capping, inspection, compression, and packaging to comply with appropriate cGMPs.
  • Manage audit observations, investigations and CAPAs records in Track Wise, participate in the investigation management process to identify RCA, evaluate, approve CAPA’s, and provide appropriate recommendations for the lot disposition.
  • Review and approve the investigations occurred in the manufacturing process, facility and utilities, microbiology and warehouse areas.
  • Review and approve the master documentation related to manufacturing and support areas such as CR’s, SOP’s, WPP’s, BOM’s, qualification and validation protocols.
  • Provide technical guidance and compliance support in the transfer of new products and process to maintain quality standards.
  • Manage audit observations, investigations and CAPAs records in TrackWise on timely manner.
  • Maintain management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials.
  • Assure that electronic systems are aligned and in compliance with cGMP’s, Regulatory Standards and requirements for domestic and international markets.
  • Provide support and training to other departments as required.
  • Participate in the risk analysis process when a quality event has happened that cannot be solved immediately and assesses the needs to be completed to continue.

BEING A FITS PIECE COMES WITH PERKS:

  • One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!

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?

Powered by JazzHR

t4YhBQuZGi

FITS LLC

Address

00674, PR
00674 USA

Industry

Manufacturing

View all jobs at FITS LLC

What email should the hiring manager reach you at?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.