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 AM.�
- 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?