Altasciences
QA Auditor
Scranton, Pennsylvania 18447
Sponsorship not specifiedDetected 31 days ago
GCPAuditingProcess ImprovementClinical Trials
About the role
- You are responsible for reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.).
- Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services).
- Works with internal clients to ensure that inspection findings are clearly communicated and understood.
Responsibilities
- Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements) to ensure regulatory compliance.
- Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
- Maintains necessary documentation of QA records and study files.
- Under supervision of a mentor/coach, performs the following tasks: SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
- Interprets GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
Benefits
- Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
- Altasciences' Benefits Package Includes:
- Health/Dental/Vision Insurance Plans
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Referral Bonus Program
- Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
- No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe.
Company info
- At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.
Equal opportunity
- equal opportunity employer committed to diversity and inclusion.
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This listing is sourced directly from Altasciences's careers page and normalized into a canonical job model.