Senior Specialist, Document Control and Training
Location: Redwood City, CA
- Rezolute is a clinical stage biopharmaceutical company dedicated to advancing therapies for rare, metabolic, and life-threatening diseases.
- In October 2020, Rezolute announced a $41 million private placement which was led by CAM Capital with Federated Hermes Kaufmann, Surveyor Capital and BVF Partners participating, among others.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead asset, RZ358, which is a potential treatment for CHI, a rare pediatric endocrine disorder.
- Rezolute is preparing to initiate a Phase 1 study, for RZ402, in Q1 2021. RZ402 is an IND-ready orally available plasma kallikrein inhibitor for the treatment of diabetic macular edema.
- Earlier this year, Rezolute received a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
The Senior Specialist / Manager, Document Control and Training is responsible for maintaining document control and document archive functions, related but not limited to change control, GXP training, CMC documentation, audits, and vendor management. The individual will also manage training assignments and tracking for employees engaged in GXP activities.
- Maintain a GMP compliant document control function facilitating appropriate processes, procedures, and practices.
- Assign and track training requirements for all employees engaged in GXP activities.
- Facilitate the process of creating, reviewing, approving, and archiving standard operating procedures (SOPs), Batch Records, Work Instructions, etc.
- Facilitate the system for the review, approval, and archiving of product specific CMO and internal manufacturing documentation.
- Facilitate the system for the management of protocols, reports, and forms.
- Ensure current versions of controlled GMP documents are readily available to site personnel.
- Maintain the document control system in compliance with all applicable regulations.
- Maintain documents related to the corporate Training System and training records.
- Maintain documents related to the corporate Quality Audit Program and track observations and coordinate responses with appropriate department managers.
- Maintain documents related to the corporate Deviation System and track deviation reports and CAPA actions.
- Create and maintain monthly QA metrics reports.
- QA support during regulatory inspections with document retrieval function, inspection logistics oversight; other functions as required.
- Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, and teamwork.
- Facilitate reconciliation of legacy hard copy and soft copy documents into a central repository in preparation for migration into an EDMS.
- 5+ years of experience in document management in a GMP regulated industry.
- BA/BS preferred with 3+ years related experience.
- Familiarity with EDMS systems (e.g., Master Control, Veeva Vault)
Preferred Experience, Special Skills and Knowledge
- Self-motivated, self-disciplined, and able to function independently as well as part of a team.
- Exceptional organizational skills and attention to details
- Strong collaboration skills and ability to prioritize, multi-task, and work in an evolving environment.
- Computer proficiency (MS Word, Excel, PowerPoint)
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.