Specialist Manufacturing ID 34471
Specialist Manufacturing ID 34471
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Job Description
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico United Sates Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job description
With minimal supervision support the execution of manufacturing/quality systems such as non-conformances process validation procedures training and new product introductions. Apply process operational scientific expertise basic compliance knowledge and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Work Shift: Administrative
Requirements
- Experience in process support especially on Drug Substance processes and process-monitoring (collect and analyze data).
- Knowledge in SAP Trackwise among others.
- Experience with electronic batch records and documents management systems.
Responsibilities
- 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 for process improvement opportunities.
- Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Change Control handling: assist manufacturing change owner on CCRB packages impacting the process.
- Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
- Responsible for managing NC/CAPA closure within established goal.
Education
- Masters degree and 3 years of Manufacturing Operations experience or bachelors degree and 5 years of Manufacturing Operations experience or associates degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
