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.
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. Administrative shift.
Competencies / Skills:
- Detailed technical understanding of bioprocessing unit operations.
- Skilled in performance of GMP production operations.
- Regulatory knowledge and interactions.
- Participate and help lead cross-functional teams.
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
- Organizational, technical writing and presentation skills.
- Basic project management skills.
- Basic knowledge of control charting.
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.
- 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.
- 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.
- Assist manufacturing change owner on CCRB packages impacting the process.
Education
Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience