Manager Quality Assurance Scientist
FITS LLC Manatí, PR
- Expired: over a month ago. Applications are no longer accepted.
For Quality services in the Manufacturing area
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology)
- Six (6) years of experience in the Quality Assurance in the industry.
- Experience in:
- Manufacturing operations of Oral Solid Dosage and Parenteral Products
- GMP, FDA, EU regulations
- Computer systems (Microsoft Office etc.), Track wise and SAP
- Batch Record review
- Isolators/Aseptic areas
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)
- Interface directly with manufacturing operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.
- Lead and participates in the critical review of all documents associated with the manufacturing operations, release, packaging and relevant activities in the operations areas.
- Ensure that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
- Provide key technical guidance and oversight to manufacturing operations areas such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure the appropriate cGMPs are in place through weekly operations audits.
- Ensure compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues.
- Provide scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.
- Support actively the investigation process occurred in manufacturing area (OSD and Parenteral products) and warehouse, Microbiology laboratory, facilities and utilities providing coaching from Quality perspective.
- Provide guidance on gaps identified from the review and actively participates to determine potential remediation activities.
- Support risk analysis process when a quality event has happened that cannot be solved immediately. This assessment needs to be completed to continue or prior to resumption of manufacturing process.
- Evaluate product impact and provide lot disposition recommendation when an investigation is completed as needed.
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