QA Auditor
Job Posting for QA Auditor at Insight Global
JOB DESCRIPTION
specifications, records and protocols. As part of the Quality Assurance Unit The QA Auditor II ensures compliance with US-FDA, US-DEA and EMA regulations.
- Ensure compliance with US FDA, US DEA and EMA regulations
- Review/approval of GMP Analytical Reports and associated electronic and hard copy data, audit trails and notebooks
- Review/approval of internal records such as:
- -Instrument calibration and maintenance
- -Training records
- -Laboratory investigations, NCRs, Complaints, Change Control
- -Internal audits
- -Review of root cause analyses, risk assessments and analyses, corrective and preventive actions, CAPA effectiveness checks
- -Review/comment on site SOPs
- Assists with internal, client, vendor and compliance audits
- Assists in policy and procedure development
- Responsible for Corrective Actions Preventative Actions (CAPA)
- Responsible for DEA activities
- Assists with computer compliance/data integrity
- Assist with monitoring and managing KPIs.
MINIMUM REQUIREMENTS
BS Chemistry, Biology or related scientific degree
4 years of related industry experience in an analytical laboratory
Experience in Laboratory GMP environment
Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/reagents, chemicals and materials
Organization, communication and analytical skills
Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
Intermediate mathematical skills, including: algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to work varied and extended hours/days, as business dictates
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