Quality Assurance Specialist na NAI

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.

Summary:

The Quality Assurance Specialist supports the Quality Systems department by helping maintain and improve the quality of products, services, and processes within the organization. This role ensures regulatory compliance, leads quality improvement initiatives, analyzes data to identify areas for enhancement, and collaborates with cross-functional teams to investigate root causes and implement effective improvements. Experience in the dietary supplement, food, pharmaceutical, or medical device industries is required. Responsibilities also include conducting internal audits, coordinating CAPA and nonconformance investigations from start to finish, and performing document control functions.
 

Essential Duties & Responsibilities:

• Prepare and implement quality systems policies and procedures.
• Document quality activities and create audit reports.
• Maintain complaint and nonconformance records and tracking systems, including conducting root cause analyses and implementing corrective actions.
• Identify training needs and make recommendations for improvement to ensure company-wide compliance.
• Develop and maintain the Foreign Supplier Verification Program (FSVP) and Supplier Qualification Program, including associated policies and procedures. Ensure that program performance and quality conform to applicable standards such as the Therapeutic Goods Act 1989, the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, FDA 21 CFR Part 111 (GMP for Dietary Supplements), and FSMA.
• Manage supplier selection, qualification, audits, improvement initiatives, and ongoing monitoring to support both new and existing materials and services.
• Review and approve supplier documentation (e.g., desktop audits, self-surveys, certifications, third-party audit reports). Prepare clear, accurate, and evidence-based supplier audit reports for management while maintaining comprehensive documentation.
• Evaluate supplier performance through product performance reviews, supplier questionnaires, and audits to identify improvement opportunities and verify corrective and preventive actions.
• Perform risk assessments as required.
• Recommend actions for supplier qualification and de-qualification by establishing and managing processes and criteria for qualification, monitoring, and issue resolution (including co-manufacturers).
• Manage supplier nonconformances and corrective/preventive actions (CAPAs), ensuring suppliers develop and implement effective plans in accordance with NCR and CAPA processes.
• Trend and track supplier audit findings and perform follow-ups to ensure CAPA completion.
• Conduct audits and post-audit meetings using industry-accepted auditing techniques and team-based approaches, leveraging interpersonal communication skills.
• Generate Product Quality Review (PQR) reports on an annual basis.
• Perform document control activities, including processing change orders from initiation to closure, data entry, and filing.
• Enter relevant data into the MRP system (e.g., BaaN), as required.
• Act as an administrator for the electronic Quality Management System (QMS) and perform the following functions:
  • Onboard new employees in the system.
  • Assign or modify employee profiles and job roles.
  • Inactivate or terminate employee profiles.
  • Perform change control activities.
  • Generate various QMS reports as needed.
  • Create training curriculums and job roles.
  • Assist with troubleshooting and password resets.
• Track and trend Quality Systems metrics.
• Perform other duties as assigned by the supervisor or manager. Any required clarification or interpretation of responsibilities will be addressed by the supervisor or manager.

Qualifications:

• Knowledge of US FDA cGMP Title 21 CFR 111 &117.
• Knowledge of Standardize Information of Dietary Ingredients (SIDI).
• Knowledge of Food Safety Modernization Act (FSMA).
• Knowledge of Foreign Supplier Verification Programs (FSVP).
• Minimum of 3-5 years auditing experience; CQA preferred.
• Minimum of a Bachelor’s degree in a related technical field or a minimum of 5 years Quality Assurance Specialist experience in food, supplement, pharmaceutical, or medical device industry required.

Required Skills/Work Experience:

• In-depth knowledge of quality assurance principles, terminology, methods, and tools.
• Strong computer skills, including proficiency with word processing, spreadsheets, databases, and electronic document change control systems.
• Demonstrates accuracy and thoroughness in day-to-day activities; continuously seeks ways to improve quality and applies feedback to enhance performance.
• Maintains a “right first time” mindset by actively monitoring own work to ensure quality.
• Proven experience in supplier management, including qualification, auditing, and performance evaluation.
• Effective leadership and interpersonal skills with the ability to influence and collaborate across plant and corporate teams.
• Solid technical knowledge of quality systems and familiarity with relevant government regulations and certification standards.
• Excellent verbal and written communication skills.
• Proficient in statistical analysis and quality-related software tools.
• Experience working with third-party auditors and certifying bodies such as SGS, NSF, ASI, USP, and TGA.
• Subject matter expertise in GMP, HACCP, Allergen Control, ISO, GFSI, and FSMA requirements.
• Strong problem-solving abilities with a track record of identifying and resolving issues efficiently.
• Decisive and confident in making timely and sound decisions.
• Demonstrates sound judgment and provides clear rationale for decisions.
• Actively involves appropriate stakeholders in the decision-making process.
• Excellent organizational skills with the ability to multi-task and work independently with minimal supervision.
• Works effectively both independently and in a collaborative team environment.

Physical/Mental Requirements:

• Must be able to work in an office or production environment.
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. 
• While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear.  The employee is frequently required to sit and stand. 

Travel Requirements:

• Must be able and willing to travel regularly between the company's three facilities located in Vista and Carlsbad, CA, as needed to support quality operations and cross-site collaboration. 
• Occasional travel may be required to perform on-site audits and inspections of supplier facilities, both domestic and/or international. This is not a primary function of the role and is typically limited to up to 1–2 times per year.

NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, intersectionality, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Upon this conditional offer of employment, a satisfactory completion of a background check (including criminal records check) with submission and passing a pre-employment post offer drug test is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information.

Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. Upon successful completion of the background check process, we will determine the date when your employment begins. NAI utilizes E-Verify to electronically verify employment eligibility.