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Document Control Specialist
Document Control SpecialistPrecigen • Germantown, MD, US
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Document Control Specialist

Document Control Specialist

Precigen • Germantown, MD, US
30+ days ago
Job type
  • Full-time
Job description

Quality Assurance Position

This position will be responsible for the daily operations of issuing, reconciling, filing, etc. of controlled documents and records in accordance and compliance with Precigen's Quality Systems, GxP regulations, and company procedures/policies.

Duties and Responsibilities:

  • Execute the daily functions of the document control process including but not limited to: formatting documents, tracking documents through the review/approval cycle, issuing documents for execution, reconciliation of issued records, and archiving.
  • Scan, organize, maintain, and file documents, adhering to the company's document lifecycle procedures. Includes both paper-based and electronic filing.
  • Issue labels for finished products and Quality Control samples
  • Support overall QA functions; perform additional duties as assigned by supervisor.

Education and Experience:

  • High School diploma, Associate or Bachelor's Degree or commensurate experience.
  • Minimum five (5) years of experience in a regulated work environment.
  • Experience with document control systems; experience with Veeva is a plus.
  • Experience working within a GxP pharma/biologic environment is a plus.
  • Strong understanding and use of Microsoft Office Suite and Adobe Acrobat Pro.

Desired Key Competencies:

  • Ability to understand and execute on the company's mission and values.
  • Exceptional organization skills with strong attention to detail.
  • Strong interpersonal skills including clear communication in both oral and written form.
  • Demonstrated ability to work with and coordinate demands from multiple stakeholders.
  • Exhibition of the highest degree of ethical standards and trustworthiness.
  • Responsive, can-do attitude.
  • Deals with conflict in a direct, positive manner.
  • Ability to think and adapt to a rapidly changing environment and demands.
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Document Control Specialist • Germantown, MD, US

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