Archivist
- 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.
- 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.
- Familiarity with ISO 9001:2015 Quality Systems preferred.
- 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.
- 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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