["QA Batch Record Review Specialist","QA Batch Record Review Specialist"]

QA Batch Record Review SpecialistContract-to-Hire | Albany, NY (100% On-site) | Mid-August 2026 StartEngagement Type: 3-Month Contract with permanent conversion opportunityLocation: Albany, NY — 100% On-siteStart Date: Mid-August 2026Pay Rate: $45 – $65/hr (W2) | Based on experienceExperience Level: 3-5 YearsABOUT THE OPPORTUNITYPlanet Pharma is partnering with a 503B outsourcing facility in Albany, NY to place a Quality Assurance Batch Record Review Specialist. This is not a purely desk‑based role, the right candidate brings both strong QA documentation skills and genuine shop floor experience in a sterile or aseptic manufacturing environment. You will be responsible for thorough, accurate, and compliant review of batch production records while maintaining a visible, engaged presence on the production floor. The facility operates smaller batch volumes with a manageable documentation load, and uses Data Ninja and NetSuite as their primary systems.WHAT YOU'LL BE DOINGBatch Record Review & Documentation ControlPerform detailed review of Batch Production Records (BPRs), ensuring completeness, accuracy, and compliance with cGMP and 503B requirementsVerify all critical manufacturing steps, in‑process checks, component usage, equipment logs, and operator entriesEnsure reconciliation of materials, components, and labelsReview associated documentation including environmental monitoring results, equipment calibration records, sterilization records, and deviation reportsManage a manageable review volume — maximum one batch per day, with smaller batch sizes and lean documentation packagesShop Floor Presence & Aseptic Processing ComplianceMaintain active shop floor presence to support real‑time documentation compliance and QA oversight during manufacturing operationsConfirm documentation supports aseptic technique, cleanroom behavior, and contamination control expectationsEnsure all required pre‑ and post‑processing checks (line clearance, equipment setup, environmental conditions) are properly documentedServe as a visible quality partner on the floor — not just a back‑office reviewerDeviation, Investigation & Change Control SupportIdentify documentation gaps, errors, or potential deviations during record review and elevate accordinglyInitiate and support investigations related to batch discrepancies, environmental monitoring excursions, or equipment issuesCollaborate with QA and Operations to ensure corrective actions are documented and effectiveBatch Release Support & Data IntegrityPrepare batch record review summaries and release recommendations for QA managementEnsure all documentation meets ALCOA+ data integrity principlesMaintain strict adherence to batch release timelinesNavigate Data Ninja and NetSuite for documentation management and record trackingSupport internal audits and FDA inspections by presenting batch documentation and responding to technical questionsWHAT WE'RE LOOKING FORBachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related field3-5 years of experience in aseptic pharmaceutical manufacturing, sterile injectable production, or 503B manufacturingShop floor experience is required – candidates with purely desk‑based QA backgrounds will not be consideredStrong knowledge of cGMP, Annex 1, USP //, and FDA 503B guidanceExperience reviewing batch records and manufacturing documentation in a sterile or aseptic environmentFamiliarity with eQMS or manufacturing documentation systems — experience with Data Ninja or NetSuite a plusHigh accuracy, strong attention to detail, and excellent cross‑functional communication skillsComfortable operating in a fast‑paced, highly regulated 503B manufacturing environmentCONVERSION OPPORTUNITYThis engagement begins as a 3‑month contract with the opportunity for permanent conversion based on performance and mutual fit. Permanent compensation will be discussed directly between the candidate and the client at the time of conversion.#J-18808-Ljbffr