Specialist I, Quality Operations

Bora Pharmaceuticals•Baltimore, MD

9d•Onsite

About The Position

This position provides technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities within the Quality Assurance Department. It helps ensure compliant, capable, and reliable operations through investigation and root cause analysis, risk assessment, review of validation and qualification documentation, performance-trend analysis, change-control and technology-transfer support, and sustainable corrective actions and process improvements. The position is on-site and full-time. The role provides technical quality oversight for assigned manufacturing processes, products, equipment, facilities, and client programs, and works across departments to resolve complex quality and compliance issues. It also supports annual product reviews, regulatory submissions, client responses, inspections, audits, quality metrics, dashboards, and management reviews. The position may include training using Virtual Reality and/or AI.

Requirements

Bachelor’s degree in engineering, pharmaceutical science, life sciences, or a technical discipline.
5–7 years of experience supporting pharmaceutical, biologics, or other regulated manufacturing operations; CDMO experience or sterile finished required.
Experience leading or supporting deviations, investigations, OOS/OOT events, complaints, and other non-conformances using structured root cause analysis methods.
Experience developing, implementing, and assessing the effectiveness of corrective and preventive actions.
Working knowledge of process validation, equipment and facility qualification, change control, technology transfer, and continued process verification.
Ability to analyze process and product data using statistical tools, identify trends, and translate findings into risk-based recommendations.
Ability to evaluate process capability, product performance, and quality-system effectiveness and recommend sustainable improvements.
Strong technical writing skills and experience reviewing and authoring investigations, protocols, reports, risk assessments, procedures, specifications, and regulatory or client-facing documentation.
Advanced knowledge of cGMP requirements, applicable FDA and EU regulations, ISO standards, and other relevant industry guidance.

Responsibilities

Provide technical quality oversight and support for assigned manufacturing processes, products, equipment, facilities, and client programs.
Partner with cross-functional departments to resolve complex quality and compliance issues.
Lead or support investigations of deviations, complaints, PAs, OOS, OOT, and other non-conformances using structured root cause analysis tools.
Develop, evaluate, and monitor corrective and preventive actions for timely completion and sustained effectiveness.
Perform quality risk assessments, impact assessments, and gap analyses for processes, products, equipment, facilities, and proposed changes.
Review and approve protocols, reports, specifications, procedures, and technical documentation related to validation, qualification, stability, and continued process verification.
Evaluate process capability, product performance, and quality-system data; identify adverse trends and recommend actions.
Apply statistical and analytical tools to investigations, trend analysis, risk-based decisions, and process improvement.
Provide quality expertise for change controls, process changes, equipment or facility modifications, technology transfers, and new product introductions.
Identify opportunities to improve process robustness, reliability, compliance, and operational efficiency, and support implementation of approved improvements.
Support annual product reviews, regulatory submissions, client responses, inspections, and audits with technical assessments and quality documentation.
Serve as a technical quality resource for cross-functional teams and communicate risks, recommendations, and decisions to stakeholders.
Support development and maintenance of quality metrics, dashboards, and management-review inputs.
Maintain current knowledge of cGMP requirements, applicable regulations, industry standards, and site procedures.