The Document Control Coordinator is responsible for assisting the Regulatory Compliance Director with the development of Standard Operating Procedures (SOPs), ensuring all employee training records are current and complete, and for developing and managing the Document Control System. Responsible for performing the duties of the Back-up GLP Archivist.
Responsible for assisting management, study directors/investigators, and staff with the development of Institute-wide Standard Operating Procedures (SOPs) and data collection forms.
- Provides guidance in the development of regulatory compliant procedures and data collection forms
- Reviews SOPs for compliance with applicable regulations and industry standards and for internal consistency
- Chairs the SOP Task Force working group
Responsible for the development, management, and maintenance of the document control and distribution system of SOPs and forms.
- Assigns SOP and form numbers
- Ensures proper SOP formatting
- Ensures proper SOP language
- Distributes SOPs and Forms for use by Texas Biomed Personnel
- Maintains an organized file of the current original, signed SOP documents
- Maintains a historical file of original SOPs
- Maintains a historical SOP Index and current SOP Indices
- Generates SOP Change Notifications and SOP Training Records when SOPs are created or revised
- Generates SOP Training and Proficiency Record to be signed and dated when notified by supervisor that employee has been appropriately trained in SOPs applicable to their position
- Ensures internal intranet SOP postings are current
Assists, as needed, with management of comprehensive employee training files to ensure that Texas Biomedical Research Institute/SNPRC employee training files contain current and complete training information to ensure regulatory compliance (e.g., resumes or CV’s, job descriptions, training documentation such as sign-in sheets and quizzes, and Standard Operating Procedure Training and Proficiency).
- Assists, as needed, in ensuring that Select Agent Training material is tracked and updated annually or more often if needed
- Enters training data into the QC Texas Biomedical Research Institute employee training database, as needed
- Assists in preparing materials for training programs and meetings, as needed.
Back-up GLP Archivist Duties: Establish and maintain archive systems for GLP study records and materials.
- Tracks disposition of GLP Study documents and materials with internal groups, CRO Archivists, and appropriate service providers.
- Identifies and assists in the improvement of internal QC procedures and tools for the management of records and data generated at Texas Biomed.
- Ensures internal consistency of materials submitted to meet the applicable regulatory requirements.
- Independently participates in cross-functional teams providing GLP guidance and risk based options.
- Solid understanding of GLP regulations, applicable SOPs and document control systems.
- Independently collaborates with specific functional groups providing guidance on SOPs (i.e. content, quality, SOP lifecycle) and addresses any documentation needs.
- Competency or experience with Electronic Document Management Systems (EDMS).
- Provides support during regulatory inspections and internal functional group audits. Solid understanding of documents governing the inspection readiness.
EDUCATION/EXPERIENCE/SKILLS: Required: BS degree in Animal Science/Biology or related field. Three or more years of relevant nonclinical/preclinical research experience. Knowledge of an extensive body of rules, procedures, or operations; specialized skills that may be technical or non-technical, such as research and analytical skills, composing non-routine documents and letters, ability to use software in complex applications. Preferred: Master’s degree. Five years of relevant nonclinical/preclinical research experience.
POTENTIAL HAZARDS: Work is performed within routine office environment with no exposure to hazardous or unpleasant conditions. Physical demands are usually limited to sitting or standing in one location much of the time. Some stooping, lifting or carrying objects of light weight may be required.
OTHER: This is a full-time hourly paid position. Texas Biomed business hours are Mondays through Fridays 8:00 a.m. to 5:00 p.m. Texas Biomed is committed to a drug-free workplace. Pre-employment drug screen is required.
Apply online at http://www.txbiomed.org/about/employment. Application packets are accepted electronically or in hard copy. A completed application packet is a requirement for all positions. Incomplete applications will not be accepted. Equal Employment Opportunity/M/F/Disability/Protected Veteran Status
Your resume and application must be provided electronically. Please follow the steps below.
- Please read instructions before submitting your application.
- PDF forms will need to be completed, saved to your computer and uploaded. Please refer to Step 2 for additional information.
- Fill out the online form.
- At the conclusion of the application process, you will be asked to attach your PDF files.