Quality Assurance Manager; Chemistry

The Chemistry Quality Assurance Manager is responsible for final quality review and disposition of chemistry testing data supporting batch release for compounded and pharmaceutical products. This role serves as the QA authority for batch certification, ensuring all analytical results, investigations, and documentation meet cGMP, USP, and FDA expectations prior to product release.

This position bridges Quality Assurance and Chemistry QC, providing independent oversight of analytical data, enforcing data integrity standards, and ensuring that all batch-related decisions are scientifically justified, compliant, and inspection‑ready.

Hours /

Location:

Full Time, Onsite

Prompt Praxis Laboratories (PPL), founded in 2011, is a women‑owned analytical and microbiology lab specializing in rapid testing, analytical development, and comprehensive support services. Leveraging modern technology and automation, PPL delivers accurate, high‑quality results for Pharmaceutical, Compounding Pharmacy, and Medical Device clients.

Committed to scientific excellence, data integrity, and operational innovation, PPL provides cost‑effective solutions that ensure safe, effective drug products. PPL offers a competitive total rewards package, including 401(k) matching, comprehensive employee benefits, and ongoing professional development.

Batch Disposition and Product Release Decision‑Making;
Chemistry Data Review and Interpretation; cGMP and Regulatory Compliance;
Investigation and Risk Assessment;
Data Integrity and Documentation Excellence;
Cross‑Functional Influence;
Audit Readiness and Inspection Defense;
Team Leadership and Accountability

• Serve as the QA approver for batch release, ensuring all testing, documentation, and investigations are complete and compliant.
• Perform final disposition decisions for in‑process, finished product, and stability batches.
• Ensure no product is released until all data, deviations, and investigations are fully resolved.
• Assess product impact and patient risk associated with atypical or out‑of‑trend results.

• Conduct independent QA review of analytical data including assay, impurities, stability, and physical testing results.
• Verify accuracy, completeness, and traceability of raw data and reported results.
• Ensure analytical methods and execution meet validated and regulatory standards.
• Provide critical evaluation of analyst conclusions to ensure scientific soundness.

• Review and approve OOS, OOT, deviations, and laboratory investigations impacting batch release.
• Ensure investigations establish clear root cause and effective CAPAs.
• Partner with QC and QA teams to ensure investigations are timely and defensible.
• Prevent premature batch release where investigation outcomes remain unresolved.

• Ensure adherence to cGMP, FDA guidance, and USP standards for batch release testing.
• Review and approve SOPs related to data review and batch disposition.
• Maintain strong knowledge of regulatory expectations related to data integrity.
• Support continuous improvement of quality systems and workflows.

• Partner with Chemistry QC, Operations, Sample Management, and Client Services to align on priorities and timelines.
• Provide QA guidance on analytical execution and investigation strategy.
• Support communication of batch‑related quality decisions to stakeholders and clients.

• Serve as a subject matter expert during audits and regulatory inspections.
• Defend batch disposition decisions and data review practices.
• Ensure all documentation is inspection‑ready and compliant.

• Lead and manage QA staff supporting batch release.
• Establish scheduling to support throughput and release commitments.
• Provide coaching and mentoring to develop technical capability and decision‑making.
• Drive accountability, performance management, and team engagement.

• Identify trends in batch failures and analytical issues to drive improvements.
• Lead…