What are the responsibilities and job description for the Quality Assurance Associate position at Clinical Resource Network (CRN)?
Our client is looking to fill the position of Quality Assurance Associate. This position will be fully remote
Responsibilities :
- Responsible for batch record review to support commercial product release (API, drug product, and finished packaged product as assigned).
- Author and review all related documentation for the Quality group including Protocols, Reports, SOPs, Risk Management, Quality Agreements, Instruction Manuals, CAPAs, Deviations, Specifications and Change Controls.
- Collaborate with other internal groups to establish Specifications, Bill of Materials, and Master Batch records related to commercial products.
- Work with the External Service Provider team for review of process improvements, deviation root cause analysis, corrective actions, OOT and OOS as required.
- Utilize TrackWise Digital for documentation and maintenance of Quality Events (QEs), Change Controls, Batches Records as assigned.
- Assist with all internal and external audit preparation as required.
- Analytical documentation review to include stability reports, OOS and retention reports.
- Support and assist with Annual Quality Product Review reports for commercial products.
Required Qualifications :
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn .
Opportunity Awaits.
