Manager, Quality Assurance Scientist

For Compliance services in the Quality area.

 WHAT MAKES YOU A FIT:  

The Technical Part:

• Bachelor’s Degree in Chemical Engineering, Biology, or Microbiology Science & five (5) years of experience in the Pharmaceutical Manufacturing industry. 
• Bilingual (English & Spanish)
• Shifts: 12-hour night shifts and weekends.
  • 5:00 PM - 5:00 AM
• Experience in:
  • Quality Assurance & cGMP Compliance
  • GMP Document Approval
  • Investigation & Root Cause Analysis
  • Cross-Functional Collaboration

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 of 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 Be The Piece?

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

• Ensure all manufacturing and support area operations comply with domestic and international cGMP regulations and company policies. This includes leading audits and providing guidance to various departments to ensure adherence to quality standards.
• Lead the critical review and approval of a wide range of GMP documents, including batch records, SOPs, protocols, and validation reports. Evaluate documentation for compliance with data integrity and electronic systems requirements.
• Provide scientific and technical input for investigations.
• This involves identifying root causes, evaluating product impact, and ensuring that Corrective and Preventive Actions (CAPAs) are effective and aligned with identified gaps.
• Serve as a quality representative and subject matter expert on various site teams and projects.
• ​​​​​​​Provide technical guidance and coaching to manufacturing, QC, engineering, and other support teams to maintain quality standards.
• Actively participate in risk analysis processes and perform trend analysis to identify opportunities for process and product quality improvements.
• Provide quality assurance support for new product transfers, and participate in the review and approval of validation protocols, Annual Product Reviews (APQR), and change control documentation.
• Assist management during internal and external regulatory inspections (e.g., FDA, DEA).
• Manage audit observations and other quality records within the Quality Management System (QMS).
• Keep management informed of any quality issues that could impact product quality or the timely release of materials through regular written reports.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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?