QA Investigator III

Prompt Praxis Laboratories (PPL), founded in 2011, is a women-owned analytical and microbiology laboratory 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 support safe and effective drug products.

The Quality Assurance Investigator III is a senior, hands-on individual contributor responsible for independently authoring, executing, and documenting complex laboratory and quality investigations. Reporting to the QA Manager, Investigations, this role applies to substantial experience in both Quality Control (QC) and Quality Assurance (QA) to investigate out-of-specification (OOS), out-of-trend (OOT), deviations, excursions, and Laboratory Investigation Reports (LIRs). The Investigator develops evidence-based root cause analyses, evaluates product and quality impact, proposes effective corrective and preventive actions (CAPAs), and produces clear, scientifically sound, inspection-ready investigation reports.

This position is intended for an experienced investigator who can manage a substantial investigation workload with minimal role-specific training and appropriate management oversight.

• Independently plan, conduct, and author assigned OOS, OOT, deviation, excursion, LIR, and other complex investigations from initiation through proposed closure, following approved procedures and required timelines.
• Gather and critically evaluate laboratory raw data, chromatograms, calculations, instrument and equipment records, methods, sample history, personnel interviews, and other relevant evidence; distinguish verified facts from assumptions.
• Write complete, logically organized investigation reports that clearly describe the event, scope, chronology, evidence, technical assessment, root cause or scientifically justified inconclusive outcome, impact assessment, and recommended actions.
• Apply appropriate root cause analysis tools, evaluate competing hypotheses, identify gaps, and recommend additional testing or fact-finding in coordination with the relevant technical SMEs and QA Manager.
• Assess potential impact on affected samples, batches, reported results, product quality, and patient risk as applicable; promptly escalation significant findings and potential release implications.
• Maintain accurate, contemporaneous, traceable records and manage multiple investigations without sacrificing depth, quality, or timeliness.

• Develop and document risk-based CAPA recommendations linked to supported root causes; define proposed owners, due dates, and measurable effectiveness criteria for management approval.
• Follow assigned investigation and CAPA actions through completion, assess supporting evidence, and flag overdue actions, ineffective corrections, or recurring events.
• Apply cGMP, applicable FDA and USP expectations, PPL SOPs, and ALCOA+ data integrity principles throughout investigation execution and documentation.
• Provide investigation-related technical input to change controls, SOP revisions, documentation improvements, and other quality system activities.

• Work directly with QC Chemistry, Microbiology, Physicals, Sample Management, Client Services, and QA to reconstruct laboratory events, challenge unsupported explanations, and obtain complete technical input.
• Prepare investigation packages and supporting evidence for internal reviews, client audits, and regulatory inspections; explain investigation rationale and findings as an assigned subject matter resource.
• Identify trends in repeat events, investigation quality, documentation deficiencies, and CAPA effectiveness; recommend practical improvements to the QA Manager.
• Provide technical guidance and constructive feedback on investigation methods and report quality to less experienced staff as assigned; this position has no direct reports.

• Demonstrated hands-on experience in BOTH QC laboratory operations and QA within a cGMP-regulated pharmaceutical, compounding, or analytical testing environment; direct knowledge of laboratory execution and quality system expectations is…