What are the responsibilities and job description for the cGMP Quality Compliance Analyst position at Nordic Naturals?

Job Description

POSITION SUMMARY

Reporting the Quality Assurance Manager, the Quality Compliance Analyst is responsible for assisting with all cGMP documentation. This includes the review and editing of controlled documents, change control processing,

and cGMP document compliance. Ensure documents and SOP’s are setup correctly to ensure compliance to State, Federal, and International regulating bodies. Duties and responsibilities include assisting site QA cGMP activities.

Other duties and responsibilities as assigned by the Quality Assurance Manager.

Specific & Required Responsibilities / 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
Able to travel for up to 10% time is required.
Review and revise SOPs and specification to ensure compliance
Assist with product review and / or release as needed.
Must have excellent verbal, written and interpersonal communication skills. Knowledge, Experience and Skills
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.
Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is a plus.
Focus on compliance while being able to minimize or reduce testing costs at all times

ESSENTIAL FUNCTIONS

Reasonable Accommodations Statement : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statement(s)

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.

Other duties as assigned.

POSITION QUALIFICATIONS

Competency Statement(s)

Leadership - Ability to influence others to perform their jobs effectively and to be responsible for making decisions.

Positive - Ability to view all situations with a positive attitude.

Innovative - Ability to look beyond the standard solutions.

Communication - Ability to communicate effectively with others using spoken and written word clearly and concisely.

Negotiation Skills - Ability to reach outcomes that gain the support and acceptance of all parties.

Strategic Planning - Ability to develop a vision for the future and create a culture in which the long range goals can be achieved.

SKILLS & ABILITIES

Computer Skills

Must be proficient with MS Office and have advanced Excel skills.

Familiarity with Smartsheet and Monday.com project management tools

Familiarity with SAP HANA is preferred. Other Requirements

High school diploma or equivalent, BA / BS Biology, Chemistry or equivalent combination of education preferred.

Certificates in HACCP, PQCI or auditing a plus.

1-2 years of experience in related field within the food or dietary supplement industry.

Work located at HQ in Watsonville, attendance mandatory on a daily basis.

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

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