Quality Assurance Specialist

For Quality services in the Laboratory area

WHAT MAKES YOU A FIT:

The Technical Part:

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.

The Personality Part:

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?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

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.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the Next Piece?