Specialist I, Quality Operations

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

• 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.

Minimum Education, Skills and Experience

• Bachelor's degree in engineering, pharmaceutical science, life sciences, or 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, 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.
• Demonstrated 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 with 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.