For Quality Services.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's degree in Science, Engineering, or a related field (or equivalent); 2–4 years of experience in Quality Assurance within a regulated industry (pharmaceutical, biotech, or medical device)
Working knowledge of cGMP, FDA regulations, and data integrity principles (ALCOA+)
Shift: 1st shift, and business needs. 8:00 AM - 4:30 PM
Experience in: Product complaint handling and investigations
Root cause analysis and CAPA
Complaint and/or service databases
Trending and statistical analysis of quality data
SOP writing and revision
GMP audit support and product review/release activities
The Personality Part:
Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Monitor and track quality detractors using the service and complaint databases
Support complaint investigations and help drive them to timely closure
Identify significant trends and report them regularly to management and cross-functional teams
Generate moderately complex statistical summaries to support quality decisions
Develop solutions to database issues of moderate scope and complexity
Write SOPs and assist others in writing and revising them
Provide advanced technical support on information mapping tools
Support product review and release functions
Support GMP audits and inspection readiness
Ensure compliance with company policies, procedures, quality standards, and safety and environmental regulations
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?