GMP Manufacturing & Process Improvement Specialist

Kindeva Drug Delivery; Lexington (KY); On-site; USD 60,000 - 80,000; Full time

Job summary

Kindeva Drug Delivery in Lexington, KY is seeking a Manufacturing Specialist to support process improvement and compliance for manufacturing activities at the Lexington facility.

You will own deviations, CAPA, and change control; review Batch Records and SOPs, and drive continuous improvement with senior staff guidance on the floor. Strong GMP knowledge and teamwork are essential for success.

Qualifications

• GMP experience required (3+ years).
• Knowledge of GMP regulations and regulatory requirements.
• Strong attention to detail and ability to manage multiple priorities.
• Excellent written and verbal communication skills.
• Ability to work with supervision and cross-functional teams.

Responsibilities

• Collaborate with QA and subject matter experts to ensure manufacturing commitments are compliant.
• Own deviations, CAPA, and change control processes and on-the-floor investigations.
• Review batch records, SOPs, and manufacturing processes; develop improvements.
• Lead continuous improvement initiatives on the manufacturing floor.
• Employ change management to train and support Manufacturing Technician staff.

Skills

GMP experience

Quality systems

Documentation control

Cross-functional collaboration

Attention to detail

Communication skills

Lean manufacturing

Teamwork

Education

HS Diploma or equivalent

BS degree in Engineering/Business/Operations

Tools

Access

Excel

ERP

Power BI

Power Apps

Electronic document management system

Job description

Kindeva Drug Delivery in Lexington, KY is seeking a Manufacturing Specialist to support process improvement and compliance for manufacturing activities at the Lexington facility.

You will own deviations, CAPA, and change control; review Batch Records and SOPs, and drive continuous improvement with senior staff guidance on the floor. Strong GMP knowledge and teamwork are essential for success.