Quality Assurance and Regulatory Affairs Coordinator (GMP)
Quality Assurance and Regulatory Affairs Coordinator/Senior Coordinator, Regulatory Affairs, is responsible for performing various administrative and logistical duties in support of the Section of Pediatric Tropical Medicine at Baylor College of Medicine vaccine initiatives. The position coordinates and administers quality assurance and regulatory research and administrative projects. The position collaborates with all members of the quality assurance and regulatory affairs team and works closely with various units in the organization and with Texas Children's Hospital Center for Vaccine Development (TCH-CVD) and its partners.
- Provides operational, administrative and logistical support for the TCH-CVD Quality Assurance and Regulatory Affairs units.
- Coordinates and participates in planning and developing QA/RA methods for project implementation and operational activities.
- Reviews records and reports of activities to ensure that progress is being accomplished toward specified TCH-CVD project objectives.
- Recommends modifications to methods or procedures as required to direct and redirect activities and ensure that objectives of TCH-CVD are met.
- Interacts with faculty, staff and students to promote the goals and objectives of TCH-CVD.
- Performs general clerical duties, including shipping of various documents and packages.
- Maintains clear communication regarding expectations.
- Takes personal responsibility and accountability for correcting any issues that may arise.
- Reviews and maintains personnel training records.
- Maintains document control systems, filing systems for both physical and electronic program files.
- Performs data entry and generates reports.
- Collaborates and participates in development of databases for TCH-CVD projects.
- Assists in managing and organizing training and advisory meetings both domestic and international, as needed.
- Prepares and distributes agendas and minutes for QA/RA meetings, as needed.
- Organizes information into spreadsheet format from data collection.
- Prepares general document templates using Adobe Acrobat and MS Word and Excel.
- Prepares and maintains electronic and/or hardcopy QA/RA documents that includes drafting, proofreading, formatting and editing.
- High School diploma or GED.
- Four years of relevant experience.
- Bachelor's degree in a health-science discipline.
- Two to five years' professional experience.
- Proficiency with MS Word, Excel and Adobe. Proficiency with document control and reference management software.
- Basic understanding and application of principles, concepts, practices and standards, and knowledge of industry practices.
- Basic understanding of GxPs (GCPs, GLPs, GMPs) and regulatory guidelines such as FDA and ICH guidelines.
- Requires excellent written and oral communication skills.
- Requires the exercise of tact and diplomacy in dealing with faculty, staff and students.
- Proficient in the use of a personal computer and Adobe Acrobat, MS Word and Excel Microsoft software programs.
- Prior experience with data management of research and regulated protocols may be required.
- Must be extremely resourceful and able to work independently, with limited supervision.
- Ability to multitask, problem solve, set and meet deadlines.
- Ability to work collaboratively with all levels of staff and range of personalities, culture and working styles.
- Excellent project management and organizational skills.
- Ability to perform detail‐oriented work with a high level of accuracy.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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