Demo

Category Manager

LanceSoft
Rockville, MD Full Time
POSTED ON 3/10/2025
AVAILABLE BEFORE 6/9/2025

Job Title : Document Control Associate / Archivist - Category Manager - Level 1

Location : Rockville BioPharma, MD 20852

DURATION : 12 Months

ttached - CLIENT0JP00105468 - Document Control Associate_Archivist - Category Manager - Level 1

  • PLEASE DO NOT SUBMIT ABOVE A MAX SUPPLIER BILL RATE OF $59.70 / hr

100% ON SITE

Job Description :

  • Prepare documentation to be sent off-site storage.
  • Management of GMP and non-GMP documentation.
  • Digitalization of Site Documents.
  • Perform transactions in MERP (SAP) system as per respective SOP.
  • Relocation of documents within Rockville Campus as per respective SOP.
  • Archive and maintain GLP and GMP documents with an accurate inventory, both on and offsite.
  • Organize the transfer of controlled documents for offsite storage.
  • Facilitate document retrieval during regulatory inspections.
  • Assist in the maintenance of the control room.
  • Archive GMP documents.
  • Keep documentation in an inspection-ready state.
  • Communicate effectively with all departments and internal customers.
  • Organize and file documents as needed.
  • Perform any other duties related to control room as assigned.
  • Education Requirement :

  • Bachelor's degree with 0-2 years of relevant experience.
  • Degree related to scientific field preferred.
  • Or 2 years' experience in Pharmaceutical formulation unit in Quality Assurance.
  • Skills :

  • Knowledge of GMP and non-GMP documentation requirements.
  • Ability to prioritize work.
  • Ability to communicate above and below the management line in case of issues.
  • Knowledge of SAP(M-ERP), MS Office Package (Excel, Access, PowerPoint, Word), and Adobe Pro Acrobat.
  • Knowledge of archival management principles.
  • Knowledge records management principles.
  • Knowledge of internal and external computer networks and software.
  • Knowledge of computers and modern office equipment.
  • Skill in management and supervision.
  • Skill in decision making.
  • Skill in research, compiling information, and preparing reports.
  • Skill in interpersonal relations.
  • Skill in oral and written communication.
  • Salary : $60 - $100

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