Aseptic Process & CAPA Specialist

INCOG BioPharma Services; Fishers (IN); Sur place; USD 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Smoke-free campus

Résumé du poste

INCOG BioPharma Services in Fishers, IN is seeking a Process Specialist to partner with operations and quality systems on deviations, CAPA, and investigations. The role demands aseptic process knowledge and the ability to influence outcomes without direct authority.

The candidate will champion cross-functional process improvements, author SOPs, conduct studies, and lead root cause analyses using tools like fishbone diagrams and 5 Whys. Strong communication and project management are essential.

Qualifications

• Experience in GMP environments and quality systems.
• Deviations investigation, CAPA, and technical writing experience.
• Strong data analysis and statistics skills.
• Excellent written and verbal communication.
• Ability to lead cross-functional projects and collaborate with ops teams.
• Familiarity with SCADA, LIMS and related documentation systems.

Responsabilités

• Support authoring, reviewing, and approving SOPs and Work Instructions.
• Direct or conduct studies to optimize operation sequences.
• Perform time studies and data collection for process improvements.
• Review productivity with operations to drive action plans.
• Maintain data integrity in batch records and reports.
• Lead or participate in root cause analyses for complex issues.
• Provide SME input on aseptic processes and filling.

Connaissances

GMP experience

Root cause analysis

Data analysis

Written communication

Cross-functional collaboration

SOP development

Time management

Project management

Quality systems

Outils

SCADA

BMS

LIMS

JMP

Minitab

Excel

Visio

Description du poste

INCOG BioPharma Services in Fishers, IN is seeking a Process Specialist to partner with operations and quality systems on deviations, CAPA, and investigations. The role demands aseptic process knowledge and the ability to influence outcomes without direct authority.

The candidate will champion cross-functional process improvements, author SOPs, conduct studies, and lead root cause analyses using tools like fishbone diagrams and 5 Whys. Strong communication and project management are essential.