Sterility Assurance Specialist - 1st Shift On-Site QA

Quva-Pharma; Bloomsbury (NJ); On-site; USD 2,617,000 - 3,857,000; Full time

Benefits offered by this job

Health benefits

401k

Paid time off

Job summary

Quva Pharma is seeking a Sterility Assurance Specialist for our 1st shift in Bloomsbury, NJ. The role focuses on ensuring sterility and quality through SOP adherence, EM/PM monitoring, and GMP compliance.

Training and collaboration with QA are essential to maintain high standards across our manufacturing environment. The position is full-time, on-site, and requires passing a drug and background check, with a set 6:00am–2:30pm schedule.

Qualifications

• High School diploma or equivalent.
• Able to pass drug and background check.
• Strong Word and Excel skills.
• U.S. work authorization; no visa sponsorship.

Responsibilities

• Ensure SOPs and QMS compliance.
• Schedule and proctor media fills.
• Read media aseptic process simulations and EM/PM plates.
• Maintain EM/PM records and sampling.
• Review EM data to identify trends.
• Provide aseptic technique and gowning training.
• Support sterility investigations and deviations.
• Support cGMP compliance and QA oversight.
• Identify and resolve events affecting quality.

Skills

Microsoft Word

Microsoft Excel

Education

High School Diploma

Job description

Quva Pharma is seeking a Sterility Assurance Specialist for our 1st shift in Bloomsbury, NJ. The role focuses on ensuring sterility and quality through SOP adherence, EM/PM monitoring, and GMP compliance.

Training and collaboration with QA are essential to maintain high standards across our manufacturing environment. The position is full-time, on-site, and requires passing a drug and background check, with a set 6:00am–2:30pm schedule.