Archivist

PharmaronCarlsbad, CA
1d$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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