Specialist I, Quality Operations

Bora Pharmaceuticals Injectables•Baltimore, MD

7d•Onsite

About The Position

This position provides technical quality support within the Quality Assurance Department for manufacturing processes, equipment, facilities, products, and product lifecycle activities. The role helps ensure operations are compliant, capable, and reliable by leading investigations and root cause analysis, assessing risk, reviewing validation and qualification documentation, analyzing performance trends, supporting change controls and technology transfers, and developing sustainable corrective actions and process improvements. The position is on-site and full-time. The role works across departments to resolve quality and compliance issues and serves as a technical quality resource for cross-functional teams. It also supports product reviews, regulatory submissions, client responses, inspections, audits, quality metrics, and management-review inputs. This position may include training using Virtual Reality and/or AI. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The listed duties describe the nature of the work but are not exhaustive; management may assign or reassign duties and responsibilities.

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.
Demonstrated experience leading or supporting deviations, investigations, OOS/OOT events, complaints, and other non-conformances using structured root cause analysis methods.
Experience developing and implementing corrective and preventive actions and assessing their effectiveness.
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 other 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 to ensure 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 associated with validation, qualification, stability, and continued process verification activities.
Evaluate process capability, product performance, and quality-system data; identify adverse trends and recommend actions.
Apply statistical and analytical tools to support 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 by providing technical assessments and quality documentation.
Serve as a technical quality resource for cross-functional teams and communicate risks, recommendations, and decisions to stakeholders.
Support the development and maintenance of quality metrics, dashboards, and management-review inputs.
Maintain current knowledge of cGMP requirements, applicable regulations, industry standards, and site procedures.