We are looking for a CAPA Board Consultant

Who is NNIT?

NNIT is one of the world’s preeminent consultancies, NNIT has served the Life Science industry for more than twenty years. A global leader in the industry, NNIT is at the forefront of the latest advances in technology – including IoT, AI, Virtual Reality, Augmented Reality, and Data Analytics – to streamline Quality Assurance, Regulatory Affairs, Clinical, Pharma Production, and Laboratory processes for our clients. Over the last four years, NNIT has experienced unprecedented growth, including our US Operations, adding more than 1,000 team members worldwide as we continue to grow with quality and speed.

Location: Hybrid -Foster City, CA (3 Days/Week)

Role:

The CAPA Consultant progresses investigations through the CAPA system. Works closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems. Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers and that required standards and/or procedural requirements are met. This role will be very visible within client interacting with directors and the VP

Requirements:

• 5 years of CAPA experience
• Previous experience in Life Sciences/Pharmaceutical Industry
• Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from ADC’s Quality System.
• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
• Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances.

Benefits:

• Health, Dental and Vision Insurance
• 401(k) Plan plus company match
• Corporate Phone Plan
• Competitive PTO
• Parental Leave

NNIT, Inc is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest, and value-adding in everything we do. Whether it is our weekly Friday meetings for all US employees or our annual company-wide Kick-Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities and provide them with “stretch assignment” opportunities to gain experience in new areas. At NNIT, we strive to have a good work-life balance for all of our employees and support a remote working model with travel only as needed; however, there may be times when projects require working at client sites to maximize NNIT’s value