Quality Assurance Specialist

We are hiring: QA Batch Record Review Specialist Location: Albany, NY (100% On-site) Experience Required: 3–5 Years QA Batch Record Review Specialist with strong shop floor experience in sterile or aseptic manufacturing environments. This is a hands‑on quality role requiring both documentation expertise and active production floor involvement. Key Responsibilities: Perform detailed review of Batch Production Records (BPRs) ensuring cGMP and 503B compliance Verify manufacturing steps, in-process checks, material reconciliation, and equipment logs Review environmental monitoring, sterilization, calibration, and deviation records Maintain active presence on the shop floor to support real-time QA compliance Support deviation investigations, CAPA, and change control activities Prepare batch release summaries and ensure ALCOA+ data integrity Work with systems such as Data Ninja and NetSuite Requirements: Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field 3–5 years of experience in sterile or aseptic pharmaceutical manufacturing Strong batch record review experience in regulated environments Hands‑on shop floor experience is mandatory Knowledge of cGMP, Annex 1, USP / / , and FDA 503B guidelines Strong attention to detail and communication skills #J-18808-Ljbffr