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Quality Assurance Auditor

4 months ago

San Diego, United States BioAgilytix Full time

**Essential Responsibilities**:

- Performs Quality Assurance (QA) audits, inspections (internal/external), and monitoring procedures against standard operating procedures, methods, protocols/plans, guidance, and/or regulations, as applicable
- Issues QA statements for reports as needed
- Reviews and assists in closing deviations, investigations, corrective actions, and preventive actions plans with management assistance
- Interacts with and attends meetings with other departments to ensure compliance with company/department/regulatory procedures and expectations
- Obtains and maintains professional and technical knowledge by attending educational workshops; reviewprofessional publications; establish personal networks
- Positively impacts the company through successful contributions, active participation, and identification of compliance gaps
- Assists in document management activities
- Assist in special projects as assigned by QA Management
- Performs duties with QA Management oversight

**Additional Responsibilities**:

- Other duties as needed

**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 responsibility

**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