Quality, Lead Investigator

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)
• Experience in:
  • Manufacturing Investigations
  • Developing, implementing, and tracking CAPAs.
  • Procedures Development and Revisions. 
  • Process Validations

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) 

• ⁠Ensures that all QEs, NTRs, NOES, and CAPAs are completed/closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
• Reviews and provides input to regulatory submissions applicable to the area of responsibility.
• Leads QE’s and CAPA’s trend evaluation.
• Participates in the new product introduction process to determine requirements for documentation, materials, training, and equipment modifications.
• Supports the establishment of process monitoring parameters and control limits.
• Supports the assessment of deviations and process monitoring data.
• Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields, and quality.
• Provides technical assistance to identify, recommend, and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects, and ensure the manufacturing area complies.
• Write, evaluate, and revise the required manufacturing documentation (i.e. SOPs, MBRs, etc.) and may assist in providing training on scientific or technical aspects of the processes
• Assists with the generation and execution of validation protocols and reports.
• Participates in regulatory inspection when necessary
• Assists the area managers and supervisory personnel to solve any production technical problem (i.e., Process/equipment troubleshooting, yield, cycle time, quality, and productivity).
• Provides alternatives and recommendations to improve and maximize processes and equipment.
• Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
• Promotes and models the client's Core Behaviors, facilitating teamwork.
• Supports all site Initiatives and any other assignments based on business needs.

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?