At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
Essential Responsibilities
- Participates in the monitoring of the Quality Management Systems (QMS), including, but not limited to, Vendor Program, Training Program, Facility/Process Inspections, Quality Metrics, or Document Management
- Ensures all Corporate GxP activities related to QMS are in in compliance with national/international GxPs
- Obtains and maintains professional and technical knowledge by attending educational workshops; reviews professional publications and establishes personal networks
- Supports conduct of regulatory inspections and audits (external and internal), by facilitating scheduling and staff coordination, accessing records, addressing inspection/audit requests, and performing other tasks, as required
Minimum Preferred Qualifications: Education/Experience
- Bachelor’s degree in biology, chemistry, other scientific or related discipline
- Not less than 3 years of experience in pharmaceutical, CRO/CMO, or similar organization
Skills:
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
- Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
- Excellent verbal and written communication skills
- Ability to deal effectively with a diversity of individuals at all organizational levels
- Acute attention to detail
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
Supervision Received
- Infrequent supervision and instructions
- Frequently exercises discretionary authority
Working Environment
- Primarily office (*i.e.,*blend of office and work-from-home)
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
- Occasional travel required
Physical Demands:
- Ability to work in an upright and/or stationary position for up to eight (8) hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
- Occasional mobility needed
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moving) objects, including files and laptop computer, with a maximum lift of 20 pounds
- Ability to access and use a variety of computer software
- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Regular and consistent attendance
Position Type and Expected Hours of Work
- This is a full-time position
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Occasional weekend, holiday, and evening work required