Sterility Assurance Specialist — 1st Shift QA

Socket.dev; Bloomsbury (NJ); On-site; USD 54,068,000 - 78,340,000; Full time

Benefits offered by this job

Health benefits and wellness

401k retirement program with company 


17 paid days off + 8 holidays

Job summary

Quva Pharma seeks a Sterility Assurance Specialist to oversee QA aspects of sterility assurance, including EM/PM monitoring. You will ensure SOP/QMS compliance, train personnel, and support investigations from a facility in Bloomsbury, NJ.

A set 1st shift schedule applies, with drug testing and background checks per policy. This full-time role requires knowledge of sterile manufacturing and FDA GMPs, plus the ability to work in a fast-paced environment while maintaining precise attention to

Qualifications

• High School diploma or equivalent is required.
• Able to pass drug and background check.
• Strong Microsoft Word and Excel skills.
• Authorized to work in the United States on a full-time basis; no visa sponsorship.
• Knowledge of sterile pharmaceutical manufacturing technologies and FDA GMP regulations for sterile products.

Responsibilities

• Ensure compliance to SOPs and QMS.
• Schedule & Proctor Media Fills.
• Read and account for EM/PM plates and environmental monitoring.
• Maintain EM/PM records and review data for trends.
• Provide aseptic technique and gowning training support.
• Support sterility investigations and deviations.
• Ensure adherence to cGMPs in the area.

Skills

Microsoft Word

Microsoft Excel

Education

High School diploma or equivalent

Bachelor's Degree in life science or related field

Job description

Quva Pharma seeks a Sterility Assurance Specialist to oversee QA aspects of sterility assurance, including EM/PM monitoring. You will ensure SOP/QMS compliance, train personnel, and support investigations from a facility in Bloomsbury, NJ.

A set 1st shift schedule applies, with drug testing and background checks per policy. This full-time role requires knowledge of sterile manufacturing and FDA GMPs, plus the ability to work in a fast-paced environment while maintaining precise attention to