Quality Auditor II
Quality Auditor II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
USD 55000 - 70000
1 Vacancy
Job Description
ESSENTIAL DUTIES & RESPONSIBILITIES: Employees must be able to perform the essential functions of the job with or without reasonable accommodation.
- Performs assigned inspections
- Reports study inspection results to StageBio management and the Study Director
- Prepares a Quality Assurance Statement for each study inspected
- Maintains a copy of study protocols
- Inspects facility records and processes
- Inspects validation packages
- Assists with client and regulatory inspections
- Assists with subcontractor inspections and vendor qualifications
- Maintains strong working knowledge of internal Standard Operating Procedures (SOPs)
- Trains StageBio Auditors as appropriate
- Participates in internal training for career development as desired
REQUIRED EXPERIENCE/EDUCATION:
- Pursuit of RQAP-GLP (Registered Quality Assurance Professional in Good Laboratory Practices) certification is encouraged but not required
- Minimum 2 years experience in a GLP quality assurance role and has completed training for at least
REQUIRED SKILLS & ABILITIES:
- Ability to monitor and report on assigned tasks goals and objectives
- Ability and willingness to meet deadlines
- Proficient with Microsoft Office Applications (Word Excel Outlook)
- Ability to work independently and in a group on a variety of projects
- Ability to maintain a high degree of accuracy attention to detail and able to hold staff accountable
- Ability to handle a fast-paced multi-tasking environment and prioritize effectively
- Capable of understanding FDA regulations
- Effective communicator both verbally and in writing
- Ability to use independent judgement concerning matters of significance
WORKING CONDITIONS / PHYSICAL REQUIREMENTS:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 5 lbs. at a time.
- Days and hours of work are generally Monday through Friday 8:00 a.m. to 5:00 p.m. with some evenings and weekends as needed
StageBio offers a comprehensive benefits package that includes employer sponsored health insurance short-term and long-term disability AD&D life insurance for employees and dependents flexible paid time off 401(k) with match and paid standard and floating holidays. Salary is commensurate with experience. StageBio is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin national origin disability or status as a protected veteran.
Required Experience:
Senior IC
Employment Type
Full-Time
