Role: Document Control Specialist
Location: San Francisco, CA
Reports to: Director, Quality Assurance and Quality Control
Status: Temporary part-time position: 24 hours / week for 6 months
PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm, a BridgeBio company, is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. Topical patidegib gel has shown early promise in a Phase 2 clinical study in Gorlin Syndrome by blocking the disease at its source within the hedgehog signaling pathway. Topical patidegib was developed to provide the efficacy previously demonstrated by oral patidegib in Phase 1 trials, but without the adverse systemic side effects of oral hedgehog inhibitors. Patidegib’s gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for ongoing, at-home management of Gorlin Syndrome.
The Document Control Specialist, QA/QC will provide support to the Quality Assurance (QA)/Quality Control (QC) and Chemistry and Manufacturing Controls (CMC) departments by assisting in the execution of GXP quality activities, including but not limited to: creation and processing of document change control documentation, management of standard operating procedures (SOPs), GXP record processing and archival, offsite record storage, employee training, support of deviation and CAPA programs, support of vendor files, and generation of quality metric reports. This role will report to Director, QA and QC and will work closely with Clinical Operations, CMC, Nonclinical, service providers, and vendors.
The Document Control Specialist, QA is expected to perform the following functions:
- Create and process document change control documentation
- Maintain paper and electronic SOP and GXP documentation systems
-Maintain document trackers and indexes for GXP activities; Quality and CMC
-Develop, update, manage, and maintain company SOPs in close cooperation with functional area representatives
-Process and archive GXP records
-Administer SOP training
-Setup and maintain GXP employee training records
-Prepare and distribute quality metric reports
-Assist in investigations of deviation and CAPA activities
-Provide general support for the overall Quality System
-Prepare documents for offsite storage
-2+ years in document or records management in a pharmaceutical cGXP environment
-Proficient with a computer (MS Office) and internet skills
-Experience of working with many file types
-High school diploma is required, Bachelor degree is preferred
-Highly organized with attention to detail
-Ability to manage multiple tasks with excellent record-keeping skills
-Excellent written and verbal communication skills
-Excellent collaborative skills
The Company is prepared to offer an attractive compensation package.
Pellepharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.