Sr. Quality Systems Specialist
Flexible & Integrated Technical Services View all jobs
- Juncos, PR
- Permanent
- Full-time
- Bachelor’s Degree in Engineering and three (3) years of exposure within the Pharmaceutical & Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent Communication skills, and Positive attitude.
- Shift: 1st Shift
- Experience in:
- Process Validation and Computer Software Validation.
- Technical writing knowledge
- Organization and communication
- Investigation and Root Cause Analysis.
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
- Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet guidelines.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages.
- Coordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.