The 1st shift Document Control Coordinator will be part of the Quality group and will work onsite at our state of art Innovation and Manufacturing facility in Winston-Salem, NC. Will utilize and be familiar with document control system requirements which include issuing numbers, document change management, circulating for review and approval; tracking at all stages of routing, approval, distribution, periodic review and storage of history files, maintenance of documentation and filing of all master documents. Ensure ongoing and timely support of project-related activities and tasks, and administrative support of Quality/Technical Services tasks., ensure accurate upkeep of all regulated documents and maintain assigned quality system records.
• Receive batch sheets, Material Issued forms, Continuation forms, Pallet Tag sheets, QA In-Process Review sheets, QA Physical Attribute forms, Request for Analysis forms, Vendor documentation (COAs, MSDS, COO, Kosher cert., etc.)
• Request for Analysis (if needed and missing) and Finished Product Release checklists
• Responsible for DCR creation, release and change implementation
• Control, maintain, retrieve and distribute official documents per the company's document control procedures
• Maintain manual and electronic tracking system of controlled documents for review and approvals.
• Perform distribution activities related to activity of controlled documents
• Update and maintain manual and electronic tracking lists, Document Control databases, and document distribution binders and logs
• Provide customer service to all employees needing assistance with GMP, GCP and GLP controlled documentation
• Perform administrative tasks to support maintenance of document and master files
• Perform all other related job duties as assigned or requested by department or company management
• Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, rules, and regulations
• Review production records to assure material meet specifications
• Responsible for Quality records filing and storage
• Support History record review and Product release
• Support Sterilization / Environmental and Pest Control documentation
WHAT’S SPECIAL ABOUT THE TEAM:
Are you ready to be part of an outstanding Quality team? We are seeking a highly skilled and motivated Document Control Coordinator to join our dynamic group. The team is a self-directed and highly motivated group that requires minimal guidance and maintains a high level of efficiency. They are results driven and proud of the work they accomplish to prevent quality defects yet humble that they tend to stay away from the spotlight.
SUPERVISORY RESPONSIBILITIES:
None
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
Skills:
• Strong organizational and time management skills
• Good interpersonal and communication skills
• Ability to communicate effectively verbally and in written English
• Computer literacy, with proven PC and software experience
• Ability to lift a minimum of 30 lbs.
• Able to work well individually and as a team member under the pressure of manufacturing
Experience:
• 2 years QA/QC experience
• Experience with SOPs
Education:
• High-school diploma (or equivalent)
PREFERRED QUALIFICATIONS:
• 2 years cGMP and customer and FDA audit experience
• Bachelor's degree or equivalent in science or a related area
PHYSICAL DEMANDS:
In general, the following physical demands 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 allow otherwise qualified individuals to perform the essential functions of the job.
Moderate: Mostly standing, walking, bending, frequent lifting
WORK ENVIRONMENT:
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
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