Nordic Naturals ยท 3 days ago
Quality Compliance Associate
Nordic Naturals is seeking a Quality Compliance Associate to assist with cGMP documentation under the direction of the Quality Assurance Manager. The role involves reviewing and editing controlled documents, ensuring compliance with regulations, and supporting QA activities in manufacturing and product launches.
Responsibilities
Assist the development, interpretation, and enforcement of Quality Systems as per corporate policy and GMP regulations under 21 CFR Part 111 and 21 CFR Part 101. Ensure proper training for QA Personnel on these GMP regulations
Provide QA support to manufacturing to ensure that requirements and specifications are met while interfacing with manufacturing partners to ensure we are testing appropriately
Provide QA support of Research and Development during new product launches and establishes key checkpoints for new products and processes
Review and edit Standard Operating Procedures (SOPs), Work Instructions, and forms to improve Quality Systems documentation that meets quality objectives
Assist with internal audits to existing company Quality Systems procedures and ensure all findings are addressed appropriately per cGMP regulations and for continued improvement to the company Quality System
Assist in FDA, CDPH, and third-party audits to meet 21 CFR Part 111. Ensure all findings are addressed appropriately to ensure continued certification and compliance to Federal and State regulations
Manage supplier qualification including current approve supplier list, associated supplier qualification activities such as establishment, documentation and auditing
Other duties as assigned
Qualification
Required
High school diploma or equivalent, BA/BS Biology, Chemistry or equivalent combination of education preferred
1-2 years of experience in related field within the food or dietary supplement industry
Demonstrates in-depth knowledge of GMPs. Strong working knowledge of cGMPs (US, Canada, and International)
Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements
Must be proficient with MS Office/Gsuite and have advanced Excel skills
Able to travel for up to 10% time is required
Must have excellent verbal, written and interpersonal communication skills
Ensure all quality documents adhere to applicable laws and standards
Assist with document control process and change control process
Perform cGMP internal audits of procedure, processes and documentation to ensure compliance
Ensure warehouse and facility compliance to NSF and FDA standards for cGMP practices
Keep training documentation for the site
Assist in external audits for potential co-manufacturer assessments
Must have a systematic problem-solving approach
Review and revise SOPs and specifications to ensure compliance
Assist with product review and/or release as needed
Preferred
Certificates in HACCP, PQCI or auditing a plus
Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is a plus
Familiarity with SAP is preferred
Familiarity with Smartsheet and Monday.com project management tools
Company
Nordic Naturals
Nordic Naturals sells vitamins and supplements.
H1B Sponsorship
Nordic Naturals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageRecent News
2025-10-28
2025-09-24
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