Investigation Specialist- 09
Flexible & Integrated Technical Services, LLC•Juncos, PR
•Onsite
About The Position
This role is within the Quality Systems area for Manufacturing Services. The ideal candidate will have a Bachelor's Degree with five years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual in English and Spanish is required, along with Project Management skills. The position involves administrative shifts according to business needs and requires experience in deviations management, Trackwise, complaints, biotech, and manufacturing.
Requirements
- Bachelor's Degree
- Five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Experience in Deviations management & Deviation assessments.
- Experience in Track wise.
- Experience in Complaints.
- Experience in Biotech and manufacturing.
Nice To Haves
- Experience in a lab environment.
- Multitasking skills.
- Scientific skills.
- Creative skills.
- Ability to work in an environment of healthy competition, teamwork, being ethical and using the scientific method.
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.
- 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.
Benefits
- Flexible scheduling
- Family-oriented environment
- Focus on employee well-being
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What This Job Offers
Job Type
Full-time
Career Level
Senior
