Specialist , Quality Operations

## Specialist I, Quality Operations Apply:
Baltimore:
Full time:
Posted Today:
9986
** About Bora
** Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.  
** Job Summary
** This position provides technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities within the Quality Assurance Department. Primary responsibilities include leading investigations and root cause analysis, assessing process and product risk, reviewing validation and qualification documentation, analyzing performance trends, supporting change controls and technology transfers, and developing sustainable corrective actions and process improvements. The role helps ensure compliant, capable, and reliable operations.

This position is on-site, full-time.  
** Essential Functions
*** Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
* * Provides technical quality oversight and support for assigned manufacturing processes, products, equipment, facilities, and client programs.
* Partners with cross-departmentally to resolve complex quality and compliance issues.
* Leads or supports assigned investigations of deviations, complaints, PAs, OOS, OOT, and other non-conformances using structured root cause analysis tools.
* Helps develop, evaluate, and monitor corrective and preventive actions to ensure timely completion and sustained effectiveness.
* Performs quality risk assessments, impact assessments, and gap analyses for processes, products, equipment, facilities, and proposed changes.
* Reviews and approves protocols, reports, specifications, procedures, and technical documentation associated with validation, qualification, stability, and continued process verification activities.
* Evaluates process capability, product performance, and quality-system data; identifies adverse trends and recommends appropriate actions.
* Applies statistical and analytical tools to support investigations, trend analysis, risk-based decisions, and process improvement.
* Provides quality expertise and insight for change controls, process changes, equipment or facility modifications, technology transfers, and new product introductions.
* Identifies opportunities to improve process robustness, reliability, compliance, and operational efficiency and supports implementation of approved improvements.
* Supports annual product reviews, regulatory submissions, client responses, inspections, and audits by providing technical assessments and quality documentation.
* Serves as a technical quality resource for cross-functional teams and communicates risks, recommendations, and decisions clearly to stakeholders.
* Supports the development and maintenance of quality metrics, dashboards, and management-review inputs.
* Maintains current knowledge of cGMP requirements, applicable regulations, industry standards, and site procedures.
* This position may be trained using Virtual Reality and/or AI.
* The above statements are intended to describe the nature of work performed by those in this…