Senior QA Document Control Specialist/Manager
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
We are seeking a highly motivated individual to be the Sr. Specialist/Manager of Document Control. This individual will report into the Director, QA Systems and play an essential role in providing oversight of document management activities to assure GxP compliance to control, storage, archival, retention, access, and handling.
The Sr. Specialist/Manager of Document Control will represent QA in driven team settings and interface with cross functional departments. The individual must have the ability to work independently and as an effective and engaged team member.
- Manage and maintain GxP controlled documents and training in Harpoon’s EDMS.
- Perform day-to-day Document Control duties independently including process Document Change Controls, review for correctness and completeness, format documents, route for review and/or approval and issue effective documents.
- Oversee formatting and controlled templates.
- Collaborate with cross functional areas to establish training applicability for new or revised documents and assist in the develop and monitoring of training curriculum/curricula on an ongoing basis to meet the relevant needs of the organization.
- Assist with on-boarding/off-boarding of Harpoon staff.
- Assist in the preparation of document control metrics and reports.
- Provide user assistance and training on document control systems and procedures.
- Participate in computer system change management and system validation activities related to the EDMS.
- Manage the archival, storage, migration, and retrieval of internal/external records (both electronic and hardcopy).
- Ensure current versions of controlled GxP documents are readily available to Harpoon staff.
- Provide support to other Quality System activities as required/requested.
Skills and QUALIFICATIONS
- Bachelor of Science in relevant science field or equivalent experience.
- 5+ year demonstrated experience in document management in a pharmaceutical/biotechnology industry.
- Experience with a 21 CFR part 11 compliant document management system (e.g. Veeva or similar systems).
- Experience in maintaining Document Control systems and programs.
- Experience with electronic Document Management System Administration
- Strong initiative in a fast-paced team environment, meets deadlines, and prioritizes work from multiple projects.
- Excellent verbal and written communication, strong organizational and interpersonal skills.
- Previous experience with regulatory inspections is a plus.