Quality Document Control Specialist (Tarrytown, NY)


Quality Assurance

The Quality Document Control Specialist will hold a key position in our Quality Department.  This individual will generate, maintain, store controlled copies and distribute current good manufacturing practices (cGMP) documents/records using different document management systems ensuring compliance with internal procedures and regulatory requirements. Will support continuous improvement activities related to document management by tracking and trending of quality system workflows and KPIs related to QMS.  

Major Responsibilities/Activities:

  • Monitor and route SOPs and other control documents for periodic review and approval per procedure in Master Control.  (Time: 15% - 20%)
  • Review controlled documents (SOP, WI, etc.) for completeness and cGMP adherence.  (Time:  10- 15 %)
  • Monitor QMS activities to ensure timely and complete responses and closures of CAPA, NCR, change control, training documentation etc. (Time:  15-20 %)
  • Maintain documents per company record retention program (Time:  5 – 8 %)
  • Prepare trending reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as SOPs, Change control, Stability, NCRs, Deviations, CAPA, APR etc.  ( Time :  10-15 % )
  • Measure and report periodic KPI/Metrics (Time 5 – 7 %)
  • Proactively work on improvement projects with quality team to improve document management system based on  best practices, expanding existing system  capabilities, trends and lessons learned.   (Time 7 – 10 %)
  • Perform other related duties and responsibilities as directed by quality management. (Time 10 – 15 %)

Minimum Requirements

  • Bachelor’s degree in the sciences preferred with 3-5 years of experience working in a FDA regulated industry.
  • Experience working with electronic document management systems like Master Control a plus
  • Knowledge of FDA 21 CFR 211, 820 and ISO 13485 a plus.
  • Excellent written and verbal communication skills with superior attention to details.
  • Strong interpersonal and communication skills to effectively work with people at all levels
  • Excellent organizational skills with ability to handle changing priorities in a fast-paced environment and able to adjust workload based on changing priorities.
  • Ability to work in an inclusive team environment as well as independently with minimal supervision.
  • Proficient with Microsoft Office products including Word, Excel, and Power point.

Prestige is an Equal Opportunity Employer

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