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Records Retention Associate

Req ID #: 213784

Charleston, South Carolina, USA

About this job

We are seeking a Records Retention Associate, for our Microbial Solutions site located in Charleston, SC.

We are seeking a Records Retention Associate, for our Microbial Solutions site located in Charleston, SC.

This position is responsible for organizing and maintaining regulated records that are secured and controlled in the records retention area. Ensure the records are compliant with current Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP) and policies. Responsible for assisting QA Auditors in performing reviews of incoming materials, with the authority for subsequent approval or rejection of these items against material specifications as well as performing QA sample checks for final product as requested.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Place and retrieve regulated records from secure and controlled access into record retention area.
  • Organize, file and retrieve batch records, protocols, and other controlled records.
  • Check-in/check-out materials from retention for regulatory and customer audits. Provide retention documents upon request for review and/or copying within the retention area.
  • Maintain inventory of content within each file cabinet/box.
  • Prepare and coordinate with all groups the disposition of documents on an annual basis including inventory of items to be disposed.
  • Evaluate and procure supplies for the Records Retention Area.
  • Scan retained documents as requested by Sr. Management. Assist QA Auditors in performing sample checks of completed batches of final product as requested.
  • Assist QA Auditors in performing reviews of incoming raw materials for compliance with requirements detailed in material specifications as requested.
  • Assure compliance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practice Regulations (GMP) for records retention area.
  • Perform all other related duties as assigned.
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About Charles River

Charles River is an early-stage Contact Research Organization (CRO). Here, we are passionate about our role in improving the quality of people's lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients' unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

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