layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Specialist, Manufacturing - ES RMD QRO at BioPharma Consulting JAD Group | LAYIQ

Initiate, revise, and approve manufacturing procedures; act as document owner ensuring alignment with current operations.
Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
Provide troubleshooting support to resolve process-related issues.
Assist in developing training materials and deliver technical/scientific training as needed.
Support establishment of process monitoring parameters and control limits.
Collect and analyze process-monitoring data; assist in deviation assessments.
Contribute to timely completion of quarterly process monitoring reports.
Ensure timely triage of non‑conformances within established goals.
Author investigation reports with clear root cause analysis and corrective actions.
Execute corrective actions and manage NC/CAPA closure within defined timelines.
Monitor and communicate incident trends.
Review equipment/system RCA investigations and support trend evaluations.
Assist in generating process validation protocols and reports.
Support execution of validation activities.
Collect, analyze, and interpret validation data.
Participate in regulatory inspections, NPIs, and process/equipment modification activities.
Support NPI assessments related to documentation, materials, training, and equipment needs.
Provide prioritization, justification, and project management support for process or equipment modification projects.
Assist manufacturing change owners with CCRB packages impacting the process.
Serve as the External Supply Quality Record Owner, managing supplier-related Change Control quality records with minimal supervision.
Lead cross-functional meetings to ensure timely progression and closure of Change Control records.
Participate in special projects, assessments, and implementation activities as assigned.
Support noncommercial activity runs for process data collection and analysis.
Skills
Strong technical understanding of bioprocessing unit operations.
Skilled in GMP production operations.
Excellent organizational, technical writing, and presentation abilities.
Basic project management skills.
Working knowledge of control charting and data trending.

Specialist, Manufacturing - ES RMD QRO

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