Quality Assurance Specialist (12-hour rotating shifts)
Flexible & Integrated Technical Services, LLC
- Manatí, PR
- Permanent
- Full-time
- Bachelor’s degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) and Six (6) years of experience in the Quality Assurance in the industry.
- Experience in:
- Experience related to a Laboratory equipment qualification documents development, execution and report as well as laboratory test method creation and configuration in the applicable instrument software.
- Regulations (Risk Assessment, Data Mapping etc.), EU regulations and the ability to interpret and apply them for intended use.
- GMP, FDA, 21 CFR Part 11 and Data Integrity.
- 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 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 take on this new challenge?
- Knowledge with network communications protocol (i.e. TCP/IP)
- Knowledge in Computerized System Validations.
- Acquainted with GAMP5 methodology for validations.
- Good skills revising validation/commissioning, and technical documentation in English and using MS Office applications.
- Fully bilingual (Spanish/English) communication skills, both written and verbal.
- Self-motivated, creative and teamwork oriented
- Technical and scientific capability to make firm decisions and recommendations
- Excellent interpersonal skills and the ability to interact with people at all levels
- Effective communication Skills
- Sense of urgency and analytical thinking
- Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP
- Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
- Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
- Willing to work irregular hours, rotative shifts, weekends and holidays when needed.