CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is pleased to announce that Sandra Cincotta has joined the leadership team to serve as Director of Quality. In this role, Sandra will be responsible for quality directives company-wide, with full authority to ensure the cGMP quality system exceeds expectations of regulatory agencies and clients alike. As such, Sandra will oversee the development and implementation of CS Analytical’s all-electronic LIMS, data capture, and quality management system; a significant investment that should serve as a model for quality and efficiency. She will assume management of all quality personnel and report directly to the CEO acting as part of the company’s executive council.

“With years of experience creating, improving, and defending cGMP contract laboratory quality systems, Sandra is an all-star when it comes to this endeavor, and we are beyond excited for her to join our leadership team,” commented CS Analytical CFO Alan Weiss. “With her credentials, she immediately makes us a stronger team and announces to our clients that quality is and will remain at the forefront of everything we do.”

“Over the past few years, I have seen a decline in the emphasis contract laboratories place on quality operations and overall client service. The opportunity to lead a team that considers investment in quality as a key corporate initiative is something I could not pass up at this stage of my career”, stated Sandra. “I look forward to advancing the CS Analytical quality program for the benefit of all stakeholders – the company, our clients, and industry as a whole.”

In todays’ complex regulatory environment, quality must be pervasive at all levels of an organization’s operation, with success requiring a keen dedication of time and financial resources. The myriad of guidance documents and regulations is constantly evolving, as is interpretation of such standards. A committed and passionate quality executive who can translate these requirements into an effective and communicable quality system is critical for success. This is even more challenging under secure, Part-11 compliant electronic settings expected today. The ability to electronically review and approve procedures and test results, host virtual audits and inspections, maintain vendors and suppliers, and implement ongoing training programs will ultimately yield time and cost savings for the primary stakeholder: CS Analytical’s clients.