DEPARTMENT: Quality Assurance/Regulatory Compliance
REPORTS TO: QAU Management (Supervisor or above)
Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under direct immediate supervision. Typically reports to a supervisor or above.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review/audit study (GLP) data, SOPs, and other research data in support study reports.
- Perform scheduled internal and vendor audits, produce Quality Assurance Inspection Reports with supervision.
- Read and understand documentation for new and current compliance procedures and regulatory enforcement trends/actions.
- Demonstrate ability to work accurately, follow instructions/schedules/timelines.
- Apply knowledge of FDA, and/or OECD and cGxP regulations and guidelines.
- Bachelor’s degree in area of specialty and 0-2 years of direct experience in the field related area; or
- High School degree or equivalent with a minimum of 4 years experience in a GXP environment and 1-2 years direct QA experience.
- Accountability – Ability to accept responsibility and account for his/her actions.
- Communication, Oral – Ability to communicate effectively with others.
- Communication, Written – Ability to communicate in writing clearly and concisely.
- Decision Making – Ability to make critical decisions with supervision.
- Detail Orientation – Ability to pay attention to the minute details of a project or task.
- Organization – Possessing the trait of being organized or following a systematic method of performing a task.
SKILLS & ABILITIES:
- Computer Skills – General computer skills including Microsoft Word, Excel, and PowerPoint.
- Animal facility and laboratories with moderate noise possible.
- Exposure to hazardous/noxious devices (e.g., needles, scalpel blades etc) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc).
- General office working conditions, with generally quiet noise conditions
- This position may require occasional duties on weekends and/or holidays.
All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
If you are interested in this opportunity please send your CV to firstname.lastname@example.org.