Archivist

PharmaronCarlsbad, CA
2d$26 - $29Onsite

About The Position

The Archivist will assist in the management and operational processes associated with archiving research documentation and laboratory materials in accordance with GLP principles and internal SOPs. This role ensures that study documentation, research records, and laboratory samples are properly organized, tracked, archived, and retrievable for regulatory and operational purposes. The Archivist will also support the review of facility and study documentation to ensure accuracy, completeness, and regulatory compliance.

Requirements

  • Bachelor's degree in a related life sciences discipline preferred (e.g., Biology, Biotechnology, Chemistry, or another Life Sciences field).
  • 2+ years of Quality Assurance experience within the pharmaceutical or biotechnology industry.
  • Experience working in a regulated environment, including familiarity with GLP or similar regulatory standards.
  • Strong written and verbal communication skills.
  • Ability to effectively communicate and collaborate with multidisciplinary teams and external vendors.
  • Strong organizational skills and attention to detail with the ability to manage documentation accurately.

Nice To Haves

  • Familiarity with ISO 9001:2015 Quality Systems preferred.

Responsibilities

  • Inventory, organize, and prepare paper study files and documentation for on-site and off-site archiving.
  • Maintain accurate inventory records for samples, specimens, blocks, and slides.
  • Package materials for archival storage, relocation, shipment, or disposal in accordance with established procedures.
  • Organize, label, and track documentation to ensure efficient storage and retrieval of research records.
  • Maintain and update tracking spreadsheets and inventory logs for archived materials and documentation.
  • Upload and manage documentation within eQCM (electronic document management system).
  • Scan, index, and organize correspondence, raw data, and controlled documents in electronic records systems.
  • Review forms, reports, tables, and study documentation to ensure accuracy, completeness, and consistency.
  • Verify documentation adheres to study protocols, SOPs, and regulatory requirements.
  • Support data integrity and quality assurance standards in accordance with GLP and internal quality systems.
  • Perform quarterly microbial test sample sampling as required.
  • Collaborate with QA teams and cross-functional staff to ensure proper documentation control and regulatory compliance.
  • Assist QA management with additional archival, documentation, and compliance-related duties as assigned.

Benefits

  • Insurance including Medical, Dental & Vision with significant employer contributions
  • Employer-funded Health Reimbursement Account
  • Healthcare & Dependent Care Flexible Spending Accounts
  • 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
  • 401k plan with generous employer match
  • Access to an Employee Assistance Program
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