QA Batch Record Review Specialist

QA Batch Record Review Specialist

• Contract-to-Hire | Albany, NY (100% On-site) | Mid-August 2026 Start
• Engagement Type: 3-Month Contract with permanent conversion opportunity
• Location: Albany, NY — 100% On-site
• Start Date: Mid-August 2026
• Pay Rate: $45 – $65/hr (W2) | Based on experience
• Experience Level: 3-5 Years

ABOUT THE OPPORTUNITY

Planet 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 Net Suite as their primary systems.

WHAT YOU’LL BE DOING

Batch Record Review & Documentation Control

• Perform detailed review of Batch Production Records (BPRs), ensuring completeness, accuracy, and compliance with cGMP and 503B requirements
• Verify all critical manufacturing steps, in‑process checks, component usage, equipment logs, and operator entries
• Ensure reconciliation of materials, components, and labels
• Review associated documentation including environmental monitoring results, equipment calibration records, sterilization records, and deviation reports
• Manage a manageable review volume — maximum one batch per day, with smaller batch sizes and lean documentation packages

Shop Floor Presence & Aseptic Processing Compliance

• Maintain active shop floor presence to support real‑time documentation compliance and QA oversight during manufacturing operations
• Confirm documentation supports aseptic technique, cleanroom behavior, and contamination control expectations
• Ensure all required pre‑ and post‑processing checks (line clearance, equipment setup, environmental conditions) are properly documented
• Serve as a visible quality partner on the floor — not just a back‑office reviewer

Deviation, Investigation & Change Control Support

• Identify documentation gaps, errors, or potential deviations during record review and elevate accordingly
• Initiate and support investigations related to batch discrepancies, environmental monitoring excursions, or equipment issues
• Collaborate with QA and Operations to ensure corrective actions are documented and effective

Batch Release Support & Data Integrity

• Prepare batch record review summaries and release recommendations for QA management
• Ensure all documentation meets ALCOA+ data integrity principles
• Maintain strict adherence to batch release timelines
• Navigate Data Ninja and Net Suite for documentation management and record tracking
• Support internal audits and FDA inspections by presenting batch documentation and responding to technical questions

WHAT WE’RE LOOKING FOR

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related field
• 3-5 years of experience in aseptic pharmaceutical manufacturing, sterile injectable production, or 503B manufacturing
• Shop floor experience is required – candidates with purely desk‑based QA backgrounds will not be considered
• Strong knowledge of cGMP, Annex 1, USP //, and FDA 503B guidance
• Experience reviewing batch records and manufacturing documentation in a sterile or aseptic environment
• Familiarity with eQMS or manufacturing documentation systems — experience with Data Ninja or Net Suite a plus
• High accuracy, strong attention to detail, and excellent cross‑functional communication skills
• Comfortable operating in a fast‑paced, highly regulated 503B manufacturing environment

CONVERSION OPPORTUNITY

This 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.