Quality Assurance Specialist Job at The Smithers Group
Job Summary
Position is responsible for conducting protocol review inspections, in-life inspections, data and report audits to assess compliance with pertinent GLPs and ensure study integrity. Also performs internal facility audits, develops audit reports, and follows up with management. Position responsibilities also include maintaining audit logs, and assisting with special assignments at the request of the QA Manager/Director. Writes audit reports to submit to Study Directors and management both electronically and hard copy. Complies with standard operating procedures regarding quality assurance, maintains QA audit files and conducts internal facility audits with follow up as needed. Must be able to understand and apply the principles and requirements of OECD, FDA and EPA GLP, as well as industry standards including FDA guidance standards, and possess a background in either chemistry or biology. Will be trained in GLPs by senior QAU staff. Must have good communication skills and interact well with people interdepartmentally as well as intradepartmentally.
Job Duties
Essential Functions
- Conduct protocol review inspections, in-life inspections, data and audit reports.
- Perform internal facility audits, create the QA report, and follow up (when applicable)
- Write protocol review inspections, in-life observations data/report audits.
- Maintain QA files.
- Special projects as requested.
- Travel to sister companies as needed to perform QA audits.
- Verbal and written interaction with staff members.
- Additional duties as assigned.
Marginal Functions
- Perform a QA review on the Master Schedule as needed.
- Perform a QA review on the training files.
- Perform vendor audits (when required)
- Meet with Study Directors to establish inspection schedule.
- GLP seminars (when available)
Physical Functions
Sitting - 80%
Standing - 10%
Walking - 10%
Reading - 75%
Speaking - 25%
Visual - 100%
Travel – 10%
Laboratory Safety
Must be able to understand and follow laboratory safety standards.
Job Specifications
B.A./B.S. in Biology, Chemistry, or related sciences. In lieu of a degree, a minimum of 4 years of related experience is acceptable. Must have good math aptitude. Will be trained in GLPs by QAU senior staff.
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