What are the responsibilities and job description for the INTERNAL ONLY - Supplier Quality Specialist position at Nature's Way?
SUMMARY
The Supplier Quality Specialist is responsible for execution of Nature’s Way supplier quality management programs to ensure suppliers and externally produced products meet or exceed corporate quality requirements and are compliant with relevant regulations including 21 CFR 111, 21 CFR 210/211, and 21 CFR 117. This is achieved through maintaining supplier documentation, resolving nonconformances and out of specifications, conducting supplier quality performance reviews, developing supplier relationships and auditing new and existing suppliers. The Supplier Quality Specialist participates in departmental and cross-functional project initiatives. This role works with Supply Chain to execute sourcing initiatives for new suppliers, with the Quality Control Laboratory when setting specifications and conducting out of specification investigations, and with Product Development to help commercialize new products.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this role include, but are not limited to, the following:
SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's degree in a science related discipline; one to two years relevant experience required, or equivalent combination of education and experience, including Current Good Manufacturing Practices (cGMPs), quality assurance or quality control practices, and basic scientific principles within Chemistry, Biology and Microbiology.
LANGUAGE SKILLS
Must have the ability to:
MATHEMATICAL SKILLS
Must have the ability to:
REASONING ABILITY
Must have the ability to:
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an Associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the Associate is regularly required to use hands to finger, handle, or feel and talk or hear. The Associate frequently is required to stand, walk, and reach with hands and arms. The Associate is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an Associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate, but individual must be able to focus and complete high-quality work despite ongoing interruptions.
The Supplier Quality Specialist is responsible for execution of Nature’s Way supplier quality management programs to ensure suppliers and externally produced products meet or exceed corporate quality requirements and are compliant with relevant regulations including 21 CFR 111, 21 CFR 210/211, and 21 CFR 117. This is achieved through maintaining supplier documentation, resolving nonconformances and out of specifications, conducting supplier quality performance reviews, developing supplier relationships and auditing new and existing suppliers. The Supplier Quality Specialist participates in departmental and cross-functional project initiatives. This role works with Supply Chain to execute sourcing initiatives for new suppliers, with the Quality Control Laboratory when setting specifications and conducting out of specification investigations, and with Product Development to help commercialize new products.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this role include, but are not limited to, the following:
- Execute processes for component and product qualification, establishing and maintaining specifications for external raw materials, packaging components, bulk, and finished goods.
- Issue supplier nonconformance notifications. Review and approve the related corrective action responses.
- Conduct thorough, accurate, and timely out of specification (OOS) investigations. Make related disposition decisions, and material reviews. Ensure that appropriate corrective and preventive actions are taken.
- Review and approve supplier deviations, rework plans, and change controls.
- Support investigations of customer complaints.
- Maintain master data and documentation, including the approved supplier list, in business information systems (SAP, Product Lifecycle Management (PLM), TraceGains).
- Facilitate the supplier qualification process and the execution of related quality agreements.
- Participate in supplier audits when needed.
- Participate in continuous improvement efforts for quality, compliance, and efficiency within processes, suppliers, and products.
- Represent QA to suppliers, customers, internal stakeholders, and on projects as assigned.
- Build relationships with Supply Chain and key suppliers to foster collaboration and continuous improvement in quality and compliance and to mitigate quality risks.
- Monitor supply quality performance with data.
- Maintain cGMP documentation and records to ensure compliance with quality standards.
- Adhere to company GMPs and policies when in production environments.
- Other duties as assigned.
SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proficiency with Microsoft Office is required.
- Multi-tasking
- Organization
- Work independently
- Technical writing skills
- Problem solving and root cause analysis experience
- Experience with enterprise resource planning systems (i.e. SAP) is preferred.
- May involve travel 1-2 times per year.
EDUCATION and/or EXPERIENCE
Bachelor's degree in a science related discipline; one to two years relevant experience required, or equivalent combination of education and experience, including Current Good Manufacturing Practices (cGMPs), quality assurance or quality control practices, and basic scientific principles within Chemistry, Biology and Microbiology.
LANGUAGE SKILLS
Must have the ability to:
- Read, analyze, and interpret general business periodicals, professional journals, scientific and technical procedures, legal documents, or governmental regulations.
- Write reports, business correspondence, and procedures.
- Respond to inquiries or complaints from fellow associates, customers, and regulatory agencies.
MATHEMATICAL SKILLS
Must have the ability to:
- Work with mathematical concepts such as probability and statistical inference.
- Apply concepts such as fractions, percentages, ratios, and proportions to practical situations
REASONING ABILITY
Must have the ability to:
- Define problems, collect data, establish facts, and draw valid conclusions.
- Interpret an extensive variety of scientific data in mathematical or diagram form and deal with several abstract and concrete variables.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an Associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the Associate is regularly required to use hands to finger, handle, or feel and talk or hear. The Associate frequently is required to stand, walk, and reach with hands and arms. The Associate is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an Associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate, but individual must be able to focus and complete high-quality work despite ongoing interruptions.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
