Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate team of core scientific, clinical, regulatory, and business leaders to bring new therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.
We envision our company culture driven by spirited individuals with an entrepreneurial mindset who want to solve problems, and leaders who are sufficiently experienced to know success in the drug development industry comes with great challenges; it will never be a straight line. We are looking for team members that are passionate about helping patients at the worst time in their lives. Rain Therapeutics strongly believes that we are tremendously fortunate to aim our careers towards having a direct impact on patients, and we intend to fully leverage this opportunity with aggressive developmental timelines for a multitude of pipeline programs, all unified across a precision oncology strategy.
Summary of Key Performance Objectives:
The Specialist, Document Control will be responsible for the management, operation, and upkeep of the Document Control System to support GxP (GMP, GLP, & GCP) programs. The core function consists of, but is not limited to: managing, developing, operating, and maintaining the Document Control System used to create, maintain and control all Quality System Documentation, which includes, but is not limited to, SOPs, protocols, instructions, guidelines and related documents. Expected to also support basic Quality Assurance activities as well. Will report to the head of Quality.
Job Duties and Responsibilities:
This position will provide support for the preparation and maintenance of quality, manufacturing, testing, inspection, and clinical documents. The responsibilities include, but are not limited to, the following:
- Create, implement, and maintain a Document Control System (electronic) that can manage both Internal and External (Contract Organization) Controlled Documents. This responsibility includes, but is not limited to, the following:
- Manage Document Change Request (DCR) System
- Distribution of Internal Controlled Documents
- Distribution of External Controlled Documents
- Periodic Audits of Document Control Systems
- If necessary, establish Documentation Control Guidelines
- Process, monitor, and maintain all controlled quality system documentation in an electronic systems used in a regulated design and manufacturing environment. This responsibility includes the creation and implementation of document and record storage, but is not limited to, the following activities:
- Maintain files for batch records for manufacturing lots
- Maintain files for studies
- Maintain files for non-conformances, CAPAs, investigations, and complaints
- Maintain files for Audits (internal and external audits)
- Maintain files for other documents that are part of the Quality System Documentation
- Ensure accuracy and integrity of Document Control system (paper and electronic systems)
- Assign document numbers
- Provide support in processing contract organization requests (e.g., coordinating review and approval of contract organization-controlled documents) in a timely and efficient manner
- Review documentation procedures and other documents to ensure compliance to relevant cGMP and cGLP requirements
- Coordinate the approval process, including facilitation and execution of documentation through document change control process
- Organizing, filing, scanning, and photocopying of all Quality System Documentation as required
- Update and Maintenance of all Document Control logs
- Provide relevant training on Document Control procedures
- Perform other related duties and responsibilities to support Document Control and QA as defined by management
- Create, implement and maintain Document Control System for Technical Protocols and Reports
- File Stability and other miscellaneous QC data
- Format and edit SOPs
- Support Clinical Files
- Provided basic Quality Assurance support.
Critical Job Skills:
- Previous Document Control experience of 1 year or more
- Basic knowledge of cGMP/GLP regulations highly preferred
- Basic Quality Assurance work experience a plus
- Knowledge of EDMS a plus such as Veeva or ZenQMS
- Demonstrated skills in using Learning Management Systems (LMS)
- Experience with BOX and Slack preferred
- Strong computer skills. Excellent Word processing skills
- Experience in Excel, PowerPoint, and Outlook, and Google calendar preferred
- Strong technical writing and editing skills
- Superior attention to detail and organization
- Strong interpersonal and communication skills
- Ability to handle changing priorities in a fast-paced environment
- Must be self-motivated and innovative in addressing routine assignments
Required and Preferred Education:
- BS/BA degree in scientific discipline from an accredited college or university or equivalent.
Physical Working Conditions:
- While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- The noise level in the work environment is usually moderate.
Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.