Job Description

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 :

• Minimum of five (5) years of combined experience within QA and/or pharmaceutical manufacturing to support commercial products.
• 2-3 years of QA experience performing batch review and release activities of contract manufacturing partners.
• Knowledge in FDA 21 CFR 211 and 210, as well as GMP requirements for commercial product release.
• Bachelor’s degree in scientific discipline.
• MS Office proficiency.
• TrackWise experience is a + or sound knowledge with a related QMS for handling deviations, complaints, CAPAs and change controls.

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.

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