Specialist Manufacturing (rotative shifts)
- Posted: over a month ago
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:
- 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 are looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Support manufacturing operations areas (OSD) 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
TechnologyView all jobs at FITS LLC
What email should the hiring manager reach you at?