Quality Assurance Associate (cGMP Compliance)

Job Description

Job Description

Position Summary

Reporting to the QA Manager, the QA Associate (cGMP Compliance) is responsible for supporting regulatory and operational compliance across the organization. This role includes reviewing and managing controlled documents, processing change controls, and ensuring adherence to state, federal, and international regulatory requirements for our food and supplements industry. The QA Associate will assist with internal audits, training documentation, and risk assessments to maintain a strong compliance framework. Additional duties may be assigned as needed.

Specific & Required Responsibilities / Skills :

Ensure all compliance-related documents adhere to applicable laws and industry standards.

Assist with the document control and change management processes.

Conduct internal audits of policies, procedures, and documentation to ensure regulatory compliance.

Monitor facility compliance with relevant regulatory bodies, such as FDA and NSF.

Maintain training documentation and assist in compliance-related training programs.

Support external audits, including assessments of third-party manufacturers.

Assist in the review and revision of policies, procedures, and specifications.

Provide compliance support across departments, including manufacturing and product development.

Maintain a systematic, problem-solving approach to compliance challenges.

Ability to travel up to 10% as required.

Strong verbal, written, and interpersonal communication skills.

Knowledge, Experience, and Skills :

Demonstrates in-depth knowledge of compliance regulations (e.g., FDA, GMP, NSF).

Experience with regulatory frameworks and documentation management systems.

Familiarity with risk management tools such as HACCP or FMEA is a plus.

Ability to balance compliance requirements while maintaining operational efficiency.

Essential Functions :

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Support the development and implementation of compliance policies and procedures.

Assist in the interpretation and enforcement of compliance regulations under 21 CFR Part 111 and 21 CFR Part 101.

Provide compliance oversight in manufacturing and supply chain processes to ensure all requirements and specifications are met.

Assist in regulatory audits and ensure all findings are addressed appropriately.

Collaborate with cross-functional teams to ensure compliance in product development and manufacturing processes.

Review and update compliance documentation, including SOPs and work instructions.

Other duties as assigned.

Position Qualifications :

Leadership : Ability to influence others and drive compliance initiatives.

Attention to Detail : Strong analytical skills to ensure accuracy in compliance processes.

Communication : Ability to effectively convey regulatory requirements to stakeholders.

Problem-Solving : Ability to identify compliance risks and recommend solutions.

Strategic Thinking : Ability to anticipate regulatory trends and support long-term compliance strategies.

Skills & Abilities :

Proficiency in MS Office (Excel, Word, PowerPoint) and familiarity with compliance software.

Experience with QMS software (e.g., Ensure, Mastercontrol), Smartsheet, Monday.com, or similar project management tools is preferred.

Familiarity with SAP HANA is a plus.

Education & Experience :

Bachelor’s degree in Business, Compliance, Biology, Chemistry, or a related field preferred.

Certifications in HACCP, PQCI, or auditing are a plus.

1-2 years of experience in compliance, regulatory affairs, or a related field within the food, dietary supplement, or pharmaceutical industry.

Pay, Benefits & Perks :

The estimated hourly pay for this role is $25.00 to $33.00. This pay is an estimate and the exact compensation may vary depending on an applicant's location, skills, prior experience, professional qualifications, and other relevant factors. Additional compensation may also include incentive compensation (i.e. bonus or commission) if applicable.

At Nordic Naturals, ‘step one’ toward achieving our goal of a healthy world is taking care of our family of employees. We offer a comprehensive and attractive benefits program to employees and eligible family members. Our benefits & perks include the following :

• Multiple Health Plan Options
• Dental & Vision
• Dedicated Mental Health & Wellness Plan
• Access to Multiple EAP Plans
• Employer Paid Life Insurance
• Paid Holidays (9 holidays per year)
• Paid Sabbatical (3 weeks of paid sabbatical after every 5 years of employment)
• 401(k) Retirement Plan (employer matches dollar for dollar up to 3%)
• Free Monthly Supplements
• Product Discount Program
• Wellness Coach

Nordic Naturals is an equal opportunity employer. A pre-employment drug screening and background check are conditions of employment.

At Nordic Naturals, we’re committed to delivering the world’s safest, most effective nutrients essential to health. Our award-winning omega-3 fish oil and other foundational nutrients are research supported, expertly formulated, rigorously tested, proven effective and, best of all, great tasting. With products for the whole family, we deliver the nutrients essential for healthy living.

Nordic Naturals has been revolutionizing omega-3s since 1995, pioneering a new definition of fish oil as it relates to purity, freshness, taste, and dosage. Headquartered in Watsonville, CA, the company has expanded beyond solely omega-3s and offers complementary, foundational nutrients essential to health. Our portfolio, which is distributed to over 35 countries, includes more than 200 products in a variety of flavors and formulations for adults, kids, athletes, and pets. Family owned; Nordic Naturals works passionately to see generations of healthier, happier people around the world.

Salary : $25 - $33