Specialist Manufacturing
Specialist Manufacturing
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Job Description
For Process Services in the Manufacturingarea.
WHAT MAKES YOU A FIT:
The Technical Part:
- BachelorsDegree with four(4)years of experiencein a Scientistwithin the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrativeand according to business needs.
- Experience in:
- Process supportDrug Substanceand process-monitoring(collect and analyze data).
- SAP TrackWise electronic batch records and documents management systems.
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. If you like how this sounds then this might be the job for you. Bring it on!
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 -Conformance and CAPA.
- 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.
- Assist with generation of process validation protocols and reports.
- Participate in the NPI process to assess requirements for documentation materials training and equipment modifications.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!
Are you the next piece
Required Experience:
Senior IC
Employment Type
Contract
