For Manufacturing/Change Control services in the Quality area.
WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering with five (5) years of experience and exposure within the Pharmaceutical or Medical Devices industry. Excellent reading, writing, and speaking skills in Spanish and English.
Shift: Administrative and according to business needs Experience in: Documentation Review Change Control Compliant Sterilization Process Manufacturing activities 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 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 take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Review and approve changes in procedures and validations from a Quality Assurance perspective.
Support Quality Improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Support the development of quality engineering and quality compliance roles with the right skill sets for existing processes and product life cycle management.
Support investigations, bounding, impact evaluations, review and approval of NRs, CAPAs and customer complaints and escalates quality issues as appropriate.
Identify Manufacturing process defects by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions.
Provide support to business functions on procedural readiness execution and remediation, measuring execution and effectiveness as required.
Provide support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
Generate test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
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?
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