IT QA Consultant - CAPA

We are looking for a Quality Management/CAPA 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 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:

• Independently conduct, complete, and document critical, major, and minor investigations related to GxP operations.
• Facilitate cross-functional meetings with internal and external parties as required.
• Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
• Perform triage of incoming incidents reported to group inbox to determine if deviation is warranted and provide next step instructions to internal stakeholders.
• Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Support management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
• Responsible for maintaining tracking tools/databases.
• Responsible for sending periodic reminder notifications to leads/coordinators.
• Support management review process through development and generation of quality system metrics and trending, and escalate issues as required.
• Support the maintenance and improvement to quality systems processes, as needed.
• Work directly with operating entities and internal clients to ensure follow-up of quality issues.
• Participate in the development of training programs regarding all aspects of producing quality products, as required.
• Assist compliance audits as required.
• Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
• Participate in developing Standard Operating Procedures to ensure quality.
• Provide guidance and technical knowledge to more junior staff, monitors the performance of daily tasks as required

Requirements

• Minimum 5 years of experience in biopharmaceutical/biotechnology
• Knowledge of applicable regulatory standards and Good Manufacturing Practices
• Must have strong written and verbal communication skills
• Must be organized and able to prioritize duties and responsibilities
• Must demonstrate initiative, innovation, and sound analytical problem-solving skills
• Must be able to interact with all levels and disciplines of employees
• Must have attention to detail and solid multi-tasking skills

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

Department: Østmarken 3A, Søborg

Location: Foster City, CA (Hybrid)