QA Auditor
$65,000–$120,000 year
On-site · Malvern, Pennsylvania, United States
Malvern, Pennsylvania, United StatesOn-siteFull Time$65,000–$120,000 yearMid LevelBachelors DegreeBioanalytical Contract Research OrganizationUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Industry
Bioanalytical Contract Research Organization
Job Summary
QA Auditor I-III position responsible for auditing GMP/GxP documents, data, and computer systems to ensure regulatory and SOP compliance. The role includes training and mentoring lower level auditors, participating in client audits, CAPAs and investigations, and tracking quality metrics to drive process improvements.
Required Qualifications
- Bachelor's degree (BA/BS or higher)
- 1-7 years experience in a GxP environment
- Knowledge of regulatory requirements: GLP, GCP, EPA, OECD, 21 CFR Part 11, GDP
- Familiarity with pharmaceutical or biotechnology industry
- Ability to review detailed data and documents
- Strong documentation and communication skills
- Ability to work effectively in a team
- Ability to work with computer systems
- Ability to multitask and perform in a fast-paced environment
Desired Qualifications
- Experience conducting vendor qualifications and audits
- Experience with CAPAs and investigations
- Ability to train and mentor lower level Auditors
- Experience reviewing and authoring templates and SOPs
- Track and present quality metrics
- Review and evaluate procedures to improve quality and efficiency
- Audit system audit trails
- Participation in client audits (as needed)
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