Job Description

For Compliance services in the Quality area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Sciences and one (1) year of experience, or a Master's Degree in Sciences and relevant experience within the Pharmaceutical Manufacturing industry.
• Bilingual (English & Spanish)
• Shifts: Non-standard shifts, and according to business needs.
  • 1st - 6:00 AM - 2:30 PM.
  • 2nd - 2:00 PM - 10:30 PM.
  • 3rd - 10:00 PM - 6:30 PM.
• Experience in:
  • Quality Management Systems (QMS)
  • Equipment Validations and Decommissioning
  • Routine testing and non-complex methods.
  • GMP and GDP

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, consistently delivering top-quality results. Are you ready to Be The Piece?

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

• Executes routine testing of non-complex/compendial methods, environmental monitoring, utility testing, raw materials, etc., as appropriate for the individual role.
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product.
• Perform activities to support lab operations such as housekeeping, alarm acknowledgment, reagent preparation, inventory management, material and reagent ordering, sample pickup and discarding, and execution of work orders.
• May represent the department during regulatory inspections (or internal and external audits).
• Provides input into the scheduling of assignments by the team lead/manager.
• Perform data verification and review
• Records performance metrics
• May update QC documents for managerial review and approval.
• May lead simple projects within the team. Also contributes to complex projects.
• May train colleagues in the execution of tasks and testing
• Contributes to change controls
• Supports deviation investigations and laboratory investigations through data gathering or the interview process. May lead to no impact deviations.
• Identifies and escalates challenges & barriers to execution, suggests solutions, and participates in remediation.
• Identifies and escalates method and/or instrument issues. Also supports and may lead to solutions.
• Positive, supportive, and actively collaborates within the team.
• Actively and positively learns and participates in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team.
• Complete all required tasks compliantly and safely while consistently and intentionally modeling clients' values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).
• Perform other tasks as assigned.

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?