Change Control Specialist

For Manufacturing Services in the Quality Systems area.

About fitspr

• If you like how this sounds, then this might be the job for you.
• Bring it on!
• 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?

Responsibilities

• Administrative and according to business needs.
• Change Control processes, with hands-on expertise assessing supplier-related quality records TrackWise and SAP Non-conformance/CAPA investigation authoring and closure management Process validation protocols, execution, and data analysis The Personality Part: Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work.
• Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible.
• AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Initiate, revise, and approve manufacturing procedures.
• Ensure all procedures reflect current operations.
• Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data.
• Evaluate, plan, and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits.
• Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Requirements

• The Technical Part: Bachelor's Degree with four (4) years of experience as a Scientist within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.