Quality Assurance BRT Manager (Chemistry)

ABOUT PROMPT PRAXIS LABORATORIES

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 a commitment to ongoing professional development. Join PPL and build a career defined by excellence and impact.

POSITION DESCRIPTION

The Chemistry Quality Assurance BRT 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. The ideal candidate brings deep expertise in analytical chemistry, strong QA decision-making capability, and demonstrated experience in batch disposition within regulated environments.

CORE COMPETENCIES

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

PRIMARY RESPONSIBILITIES

Batch Release & Disposition Authority Serve as the QA approver for batch release, ensuring all required chemistry 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 and approved. Assess product impact and patient risk associated with any atypical or out-of-trend results. Chemistry Data Review & Oversight Conduct independent QA review of analytical data, including assay, impurities, stability, and physical testing results. Verify accuracy, completeness, and traceability of raw data, calculations, and reported results. Ensure analytical methods, system suitability, and test execution meet validated and regulatory standards. Provide critical evaluation of analyst conclusions, ensuring scientific soundness and compliance. Investigations, Deviations & CAPA Review and approve OOS, OOT, deviations, and laboratory investigations impacting batch release. Ensure investigations establish clear root cause, include appropriate risk assessments, and define effective CAPAs. Partner with QC and QA teams to ensure investigations are timely, thorough, and defensible. Prevent premature batch release where investigation outcomes remain unresolved. Quality Systems & Compliance Ensure adherence to c

GMP, FDA

guidance, and USP standards (<795>, <797>, <800>) for batch release testing. Review and approve SOPs related to data review, batch disposition, and analytical processes. Maintain strong knowledge of regulatory expectations related to data integrity and batch certification. Support continuous improvement of QMS processes governing batch release and testing workflows. Cross-Functional Collaboration Partner closely with Chemistry QC, Operations, Sample Management, and Client Services to align on batch priorities and release timelines. Provide QA guidance on analytical execution, investigation strategy, and release readiness. Support communication of batch-related quality decisions to internal stakeholders and clients when necessary. Audit & Inspection Readiness Serve as a subject matter expert during audits and regulatory inspections for batch release and analytical QA. Defend batch disposition decisions, investigation outcomes, and data review practices. Ensure all batch documentation is inspection-ready, consistent, and compliant. Team Leadership (Scheduling, Mentoring & Accountability) Lead and manage QA staff supporting batch release, ensuring clear ownership and accountability for deliverables. Establish and manage daily and weekly scheduling to support throughput, turnaround times, and release commitments. Provide hands-on coaching and mentoring to develop technical capability, decision-making, and QA judgment. Drive a culture of accountability, responsiveness, and right-first-time execution. Conduct performance management, including goal setting, feedback, and corrective coaching as needed. Ensure team readiness to support extended hours, surge capacity, or critical release timelines. Continuous Improvement & Leadership Identify trends in batch failures, deviations, and analytical issues to drive proactive improvements. Lead or support initiatives to enhance right-first-time performance and release efficiency. Mentor QA staff and analysts on data review, regulatory expectations, and scientific judgment. Promote a culture of quality ownership, accountability, and data integrity.

DESIRED QUALIFICATIONS

Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related discipline (advanced degree preferred). 7-10 years of QA/QC experience in a regulated pharmaceutical or compounding environment. Strong expertise in analytical chemistry (HPLC/UPLC, GC, KF, UV-Vis, FTIR). Demonstrated experience with batch release, product disposition, and QA data review. 3-5+ years of direct people leadership experience in a QA or laboratory environment. Demonstrated ability to manage team scheduling, workload balancing, and throughput demands. Proven success in mentoring and developing technical staff. Strong track record of driving accountability, performance management, and team engagement. Experience leading teams in fast-paced, service-driven laboratory operations. Proven experience with OOS investigations, deviations, CAPA, and data integrity. Experience supporting FDA inspections and client audits. Excellent technical writing and documentation review skills. Strong scientific judgment and ability to manage competing priorities. Experience with electronic QMS and LIMS systems preferred.

Pay:

$95,000.00 - $120,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person