Quality Assurance Specialist

Quality Assurance Specialist

Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements, and we are involved in every facet of the industry, including research, development, manufacturing, marketing, and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry level candidates that are interested in working for global company with opportunities for growth, development, competitive pay, and benefits.

The role of the Quality Assurance Specialist is to support the Quality Systems department by assisting in maintaining and improving the quality of products, services and processes within the organization. Responsibilities include ensuring compliance with applicable regulations, supporting quality improvement activities, analyzing data to identify areas for improvement, and collaborating with cross functional teams to investigate root causes and identify improvements to enhance processes and procedures.

Experience in dietary supplements, food, pharmaceutical or medical device industries is required. Conducting internal audits, coordinating CAPA and Nonconformance investigations from beginning to end and performing document control functions.

Essential Duties & Responsibilities:

• Preparing and implementing quality assurance policies and procedures.
• Documenting quality assurance activities and creating audit reports.
• Maintains complaint and nonconformance processing through records and tracking systems, including root cause analysis and corrective actions.
• Makes recommendations for improvement by identifying training needs and taking action to ensure company wide compliance.
• Develops and maintains the FSVP and Supplier Qualification program, policies, and procedures ensuring that program performance and quality conform to established standards, such as:
  Good Manufacturing Practices, FDA 21 CFR Parts 111 & 117, and FSMA; by actively managing supplier selection, audits, improvement, qualification, and ongoing monitoring in support of existing and new materials and services.
• Reviews and approves suppliers' documentation (ex: desktop audits, self-surveys, certifications, 3rd party audit reports). Produces clearly written, accurate, and evidence-based supplier audit reports to management while maintaining detailed documentation. Evaluates supplier performance through evaluation of product performance, supplier questionnaires, and audits to identify opportunities for improvement and confirm required corrective and preventive actions.
• Performs risk assessments, when required.
• Recommends actions relating to supplier qualification and disqualification by establishing process and criteria for supplier (including co-manufacturer) qualification, monitoring, and issue resolution.
• Manages supplier nonconformances and corrective and preventive actions, ensuring plans are developed and executed by suppliers in compliance with the NCR and CAPA processes.
• Trends and tracks supplier audit findings and performs CAPA follow-up activities through completion.
• Performs audits and post-audit meetings using generally accepted auditing techniques and tools as well as the team concept, which utilizes effective interpersonal skills.
• Performs document control activities such as processing change orders from initiation to closure, data entry, and filing.
• Perform MRP System (BaaN) entries as required.
• Engage in the electronic Learning Management System (LMS) as an administrator and perform the following activities:
• Onboarding of new employees in the software management system.
• Assign/modify employee profiles and job roles.
• Inactivate/terminate employee profiles in the software.
• Perform change control activities.
• Produce various LMS reports as required.
• Create curriculums and job roles.
• Assist with troubleshooting and password resets.
• Responsible for tracking and trending Quality Systems metrics.
• Performs other responsibilities, in addition to those mentioned above, as assigned by supervisor/manager. Any interpretation or clarification regarding the…