Essential Responsibilities

• Performs Quality Assurance (QA) audits, inspections (internal/external), and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable
• Issue QA statements for reports as needed
• Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
• Assist in writing and reviewing QA standard operating procedures
• Positively impacts the company through successful contributions, active participation and identification of compliance gaps
• Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
• Assist in document management activities
• Perform duties with minimal QA Management oversight

Additional Responsibilities

• Other duties as assigned

Minimum Preferred Qualifications - Education

• Bachelor’s degree in biology, chemistry, biochemistry, medical technology, or other scientific discipline
• Not less than two (2) years’ experience working in a laboratory/bench role/operations
• Not less than two (2) years’ experience in GLP/GCLP quality assurance (QA)
• Experience working in biotech, pharmaceutical, CRO/CMO or similar organization

Minimum Preferred Qualifications - Skills

• Internal and/or external GxP auditing experience
• 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.)

Supervisory Responsibility

• This position has no supervisory responsibilities

Supervision Received

• Frequent supervision and instructions
• Infrequently exercises discretionary authority

Working Environment

• Primarily office
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Occasional weekend, holiday, and evening work 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 lab 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 moves) objects including office materials 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
• 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