This position is responsible for maintaining document control and document archive functions, and for facilitating processes for change control, training systems, vendor management, metrics reporting, and CAPA systems.
The Specialist/Senior Specialist Quality Assurance Document Control supports the drug product manufacturing process with the following responsibilities:
- Maintain a GMP compliant document control function facilitating appropriate processes, procedures, and practices.
a. Facilitate the process of creating, reviewing, approving and archiving standard operating procedures (SOPs), Batch Records, Work Instructions, etc.
b. Facilitate the system for the review, approval, and archiving of product specific CMO and internal manufacturing documentation.
c. Facilitate the system for the management of protocols, reports, and forms.
d. Ensure current versions of controlled GMP documents are readily available to site personnel.
e. 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 for closure; assure that site managers are informed
- Maintain documents related to the Change Control System
- Create and maintain monthly QA metrics reports
- QA system 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, integration, and teamwork.
- Other duties as assigned.
- At least 2 years of experience in document management in a regulated industry.
- Able to work effectively in a fast-paced, start-up company environment.
- Self-motivated, self-disciplined and able to function independently as well as part of a team.
- Strong ability to prioritize, multi-task, and work in an evolving environment
- Strong written/verbal communication skills.
- Strong computer proficiency (MS Word, Excel, PowerPoint)