Sterility Assurance Specialist - Day Shift, Quality Impact

Quva; Bloomsbury (NJ); Presencial; USD 26 000 - 37 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Comprehensive health and wellness

401k retirement program with company 


17 paid days off + 8 holidays

Career advancement opportunities

Resumo da oferta

Quva Pharma in Bloomsbury, NJ is seeking a Sterility Assurance Specialist to oversee QA aspects of sterility, environmental/personnel monitoring, and cGMP compliance within our facility. The role is full-time, 1st shift, on-site with a safety-sensitive designation and pre-employment drug/background checks.

You will train personnel, review EM/PM data, support sterility investigations, and ensure accurate documentation and batch assessment to maintain high quality and patient safety.

Qualificações

• High School diploma or equivalent.
• Able to pass drug and background check.
• Strong Microsoft Word and Excel skills.

Responsabilidades

• Ensures company compliance to Quva Pharma’s SOPs and QMS.
• Schedule & Proctor Media Fills.
• Performs reading of media aseptic process simulations and EM/PM plates and accounting of all units.
• Maintains EM/PM records and sampling.
• Reviews EM/PM data to identify trends.
• Provides training support on aseptic techniques and gowning, including Compounder Competency Assessments.
• Supports sterility investigations including EM/PM excursions and deviation reviews.
• Ensures adherence to cGMPs and quality oversight.
• Oversees training of department personnel on new processes.
• Reviews batch data for compliance with specifications.
• Manages sampling, inspection, and control of product labels.
• Reviews shipping documentation for commercial products.

Conhecimentos

Microsoft Word

Microsoft Excel

Formação académica

High School diploma or equivalent

Descrição da oferta de emprego

Quva Pharma in Bloomsbury, NJ is seeking a Sterility Assurance Specialist to oversee QA aspects of sterility, environmental/personnel monitoring, and cGMP compliance within our facility. The role is full-time, 1st shift, on-site with a safety-sensitive designation and pre-employment drug/background checks.

You will train personnel, review EM/PM data, support sterility investigations, and ensure accurate documentation and batch assessment to maintain high quality and patient safety.