Job Description

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 companywide 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 responsibilities above will be addressed by the supervisor/manager.

Qualifications:

• Knowledge of US FDA cGMP under Title 21 CFR Parts 111 & 117.
• Knowledge of Standardize Information on 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 certification preferred.
• Minimum of a Bachelor's degree in a related technical field or a minimum of 5 years of Quality Assurance Specialist experience in dietary supplement, food, pharmaceutical, or medical device industry required.

Required Skills/Work Experience:

• Deep knowledge of quality assurance terminology, methods and tools.
• Superb computer skills, including database knowledge.
• Supplier management experience required.
• Leadership skills that enable effective interaction with and influence of plant and corporate personnel.
• Technical knowledge of quality systems; knowledge of relevant government regulations and certification criteria.
• Excellent verbal and written communication skills; computer and statistical skills.
• Experience with 3rd party audits and certification programs, such as SGS, NSF, ASI, USP, and TGA.
• Subject matter expertise in GMPs, HACCP, Allergen Control, ISO, GFSI, FSMA.
• Ability to identify and resolve problems in a timely manner.
• Ability and willingness to make decisions.
• Exhibits sound and accurate judgment.
• Supports and explains reasoning for decisions.
• Includes appropriate people in decision-making process.
• Ability to make decisions in a timely manner.
• Demonstrates accuracy and thoroughness in day-to-day activities. Looks for ways to improve and promote quality and applies feedback to improve performance.
• Monitors own work to ensure quality with a right-first-time mentality.
• Day-to-day functionality requires familiarity with word processing, spreadsheet, database, and electronic document change control systems.
• Strong organizational skills and ability to multitask and work with minimal supervision.
• Works well in a team environment and independently.

Physical/Mental Requirements:

• Must have the ability to travel.
• Must be able to work in an office or production environment.

Travel Requirements:

• Must have the ability and be willing to travel among the company's local facilities.

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.

Benefits:

• Medical plan options – Two HMO and one PPO
• Dental, vision, life insurance and other voluntary benefit options.
• 3 weeks' vacation and 11 paid holidays
• 401K including company matching and profit sharing
• $1,000 Employee Referral Bonus
• Quarterly employee lunches, Employee of Month and other recognition programs
• Opportunities for advancement
• Comprehensive training
• Tuition Reimbursement and more!
• Ability to Commute:
• Carlsbad, CA 92008 (Required)

Work Location: In person

Monday through Friday, 8:00 AM to 5:00 PM

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