Document Control Coordinator

HerbalifeWinston-Salem, NC
Onsite

About The Position

The 1st shift Document Control Coordinator will be an onsite member of the Quality group at the state-of-the-art Innovation and Manufacturing facility in Winston-Salem, NC. This role involves utilizing and being familiar with document control system requirements, including issuing numbers, managing document changes, circulating documents for review and approval, and tracking all stages of routing, approval, distribution, periodic review, and storage of history files. The coordinator will also be responsible for the maintenance and filing of all master documents. The position ensures ongoing and timely support for project-related activities and tasks, administrative support for Quality/Technical Services tasks, accurate upkeep of all regulated documents, and maintenance of assigned quality system records. The team is described as self-directed, highly motivated, efficient, and results-driven, focusing on preventing quality defects while maintaining a humble approach.

Requirements

  • 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
  • 2 years QA/QC experience
  • Experience with SOPs
  • High-school diploma (or equivalent)

Nice To Haves

  • 2 years cGMP and customer and FDA audit experience
  • Bachelor's degree or equivalent in science or a related area

Responsibilities

  • 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

Benefits

  • Group Health Programs
  • Voluntary Benefit Programs
  • Paid Time Off
  • Medical
  • Dental
  • Vision
  • Health Savings Account (HSA)
  • Flexible Spending Accounts (FSA)
  • Basic Life/AD&D
  • Short-Term and Long-Term Disability
  • Employee Assistance Program (EAP)
  • 401(k) plan
  • Wellness Incentive Program
  • Employee Stock Purchase Plan (ESPP)
  • Supplemental Life/Critical Illness/Hospitalization/Accident Insurance
  • Pet Insurance
  • Company-observed U.S. Holidays
  • Floating Holidays
  • Vacation
  • Sick Time
  • Volunteer Program
  • Paid Maternity and Paternity Leave
  • Bereavement Leave
  • Personal Leave
  • Time off for voting

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

High school or GED

Number of Employees

1,001-5,000 employees

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