Job Application for Quality Compliance Associate at Nordic Naturals

New

PAY $25 to $33 per hour

POSITION SUMMARY

Reporting to the Quality Assurance Manager, the Quality Compliance Associate 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 compliance activities. Other duties and responsibilities as assigned by the Quality Assurance Manager.

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.
Manage supplier qualification including current approve supplier list, associated supplier qualification activities such as establishment, documentation and auditing.
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.
Detail Oriented - Ability to pay attention to the minute details of a project or task.
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

Specific & Required Responsibilities/Skills:

Ensure all quality documents adhere to applicable laws and standards
Assist with document control process and chance 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

Computer Skills

Must be proficient with MS Office/Gsuite and have advanced Excel skills.
Familiarity with Smartsheet and Monday.com project management tools

Familiarity with SAP 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.

First Name

Last Name

Preferred First Name

Country

Phone

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

School

Select...

Degree

Select...

Discipline

Select...

LinkedIn Profile

Will you be able to provide proof of your identity and employment eligibility if you are hired?

Select...

Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)?

Select...

I hereby authorize Nordic Naturals, to thoroughly investigate my references, work record, education and other matters related to my suitability for employment and, further, authorize the references I have listed to disclose to the company any and all letters, reports and other information related to my work records, without giving me prior notice of such disclosure. In addition, I hereby release the Company, my former employers and all other persons, corporations, partnerships and associations from any and all claims, demands or liabilities arising out of or in any way related to such investigation or disclosure.

Select...

I hereby certify that I have not knowingly withheld any information that might adversely affect my chances for employment and that the answers given by me are true and correct to the best of my knowledge. I further certify that I, the undersigned applicant, have personally completed this application. I understand that any omission or misstatement of material fact on this application or on any document used to secure employment shall be grounds for rejection of this application or for immediate discharge if I am employed, regardless of the time elapsed before discovery.

Select...

I understand that nothing contained in the application or conveyed during any interview which may be granted or during my employment, if hired, is intended to create an employment contract between me and the Company. In addition, I understand and agree that if I am employed, my employment is for no definite or determinable period and may be terminated at any time, with or without prior notice, at the option of either myself or the Company and that no promises or representations contrary to the foregoing are binding on the Company unless made in writing and signed by me and the Company’s designated representative.

Select...

Should a search of public records (including records documenting an arrest, indictment, conviction, civil judicial action, tax lien or outstanding judgment) be conducted by internal personnel employed by the Company. I am entitled to copies of any such public records obtained by the Company unless I indicate waiver below. If I am not hired as a result of such information, I am entitled to a copy of any such records even though I have waived below.

Select...

I waive receipt of a copy of any public record described in the paragraph above.

Select...

Quality Compliance Associate

Apply for this job