GNC External Quality Systems Coordinator in Greenville, South Carolina
The External Quality Systems Coordinator is responsible for 3rd Party Contractor and raw material quality compliance program to include monitoring of approved organizations and qualification of new organizations, with primary focus on raw material, components, labeling, and contract laboratories. May include 2nd Party Contract sites, scheduling of GMP audits, identification of audit resources, and maintenance of audit documentation, conducting audits and tracking and trending of data related to the audit program. May require some travel. Is responsible for evaluating the quality of services and interactions provided by organizations within the enterprise.
Essential Duties and Responsibilities
Ongoing assistance in development, maintenance, and organization of electronic and manual files and supplier/materials/component repository.
Process ownership and fulfillment of Supplier Qualification requests
Integral participation in External Quality process improvement initiatives, as assigned by Management or Supervision
Provide internal and external customer service to ensure compliance in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, rules, and regulations
Development of Risk based approach to the quality compliance program
Development of Metrics to ensure quality compliance of organizations to meet Nutra's quality objectives
Leverage Best Practices observed into the Nutra quality organization
Supplier Qualifications (Qualifying new suppliers and requalifying established suppliers) per the established SOP's.
Inputting information into the supplier/materials/component repository to ensure all information is current per procedural requirements.
Maintain hard copy and electronic file system to insure all required repository information is included per the procedural requirements.
Review supplier complaint database to trend supplier complaints and track open CAPA's from supplier
Interface with Purchasing and other internal groups regarding Suppliers
Monitor the FDA and other applicable websites for possible warning letters, audits, and other details of suppliers/manufacturing sites.
Ensures the distribution of information and metrics as required and assigned by Management.
Plan and perform audits of the contractors, suppliers according to the requirements as specified in the respective quality model
Audits include: desktop, pre-qualification audits, routine GMP surveillance audits, for cause audits at contractors/ suppliers
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to quality directives and escalation procedures
Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Quality Systems team
Develops clear and concise written reports which describe audit findings and are used to communicate to various levels of management; Evaluates the quality and accuracy of transactions and/or communications with providers, groups, and/or policyholders. Identifies, documents, and reports any transaction errors or communications issues in a timely manner to ensure prompt resolutionAssists in development of the schedule, budget and alignment of resources to support the External Quality Compliance programsTracks and Trends data resulting from audits and any CAPA'sReview and revise relevant procedures, as needed, and support normal compliance activities upon requestAble to review audit responses and to recommend solutions that achieve desired outcomes
Conveys difficult information diplomatically and applies logical arguments when negotiating with colleagues
May require travel as required by this job description
chedules, Coordinates, Communication and issuing final reports including CAR (Corrective Action Reports) information
Maintains procedural documentation related to the RM and 3rd Party Compliance audit program
Will perform other duties as deemed necessary and assigned by the Supervisor, the Director of External Quality, or Quality Systems Manager
1-3 years external auditing experience
3 years' experience driving corrective and preventive actions
5 years' experience managing quality systems or compliance in a manufacturing of Dietary supplement, Pharmaceutical or acceptable food industry
3 years' experience managing and conducting audits for the Dietary supplement, Pharmaceutical or acceptable food industry
Bachelor of Science degree in Science related field (food science, biology, microbiology, chemistry, other) or equivalent job experience
ASQ-CQA or Lead Auditor Certification, HACCP and/or PCQI Training/Certification
Strong organizational and written/verbal communication skills, must have strong technical writing abilities
Self-motivated with the ability to effectively work with others in various disciplines and to prioritize tasks in a deadline-driven environment
Able to understand GMP requirements and Quality Management System requirements (both domestic and international)
Able to travel via car, plane and/or train (passport strongly recommended)
Able to research and prepare focused audit based on manufacturing process
Able to represent the company in a professional and ethical manner while at any location on company business
Proficient in Microsoft office products (MS Word, Excel, PowerPoint, etc.)
The physical demands described here are representative of those that must be met by an employee 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 employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision.
Requires sitting, standing, walking and overnight travel
The work environment characteristics described here are representative of those an employee 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. Manufacturing, Laboratory, Office and Warehouse Environments. PPE as required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This job description reflects management's assignment of essential job functions, which are not intended to be an exhaustive list of all responsibilities, duties and skills required.