Onsite 6-Month Manufacturing Specialist, GMP Focus

ProQuality Network; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

ProQuality Network is seeking a Manufacturing Specialist to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role emphasizes GMP compliance, process ownership on selected platforms, and collaboration across operations, quality, and maintenance.

The ideal candidate will apply scientific and analytical skills to drive process improvements, ensure regulatory compliance, and serve as a primary process

Qualifications

• Doctorate or advanced degree in Engineering, Life Sciences, Biotechnology, Chemistry, or related field.
• Experience in regulated manufacturing environments (pharma/biotech/medical device).
• Familiarity with automation, process equipment, and Lean Six Sigma/Kaizen/RCAs.
• Ability to troubleshoot, implement CAPAs, and drive process improvements.
• Cross-functional collaboration with operations, quality, and maintenance teams.
• Strong GMP knowledge and regulatory documentation practices.
• Excellent communication and attention to detail.

Responsibilities

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Serve as document owner ensuring procedural compliance across production.
• Assess process performance and implement efficiency/quality improvements.
• Provide troubleshooting support for manufacturing issues.
• Assist in generating training materials on technical manufacturing topics.
• Support process monitoring parameters and deviation assessments.
• Contribute to quarterly monitoring reports and CAPA management.
• Participate in regulatory inspections and NPIs.

Skills

Bioprocessing

GMP familiarity

Regulatory knowledge

Cross-functional leadership

Communication skills

Documentation

Technical writing

Project management

Data analysis

Control charts

Education

Doctorate Degree

Master’s Degree + 2 years experience

Bachelor’s Degree + 4 years experience

Associate Degree + 8 years experience

High School Diploma / GED + 10 years experience

Job description

ProQuality Network is seeking a Manufacturing Specialist to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role emphasizes GMP compliance, process ownership on selected platforms, and collaboration across operations, quality, and maintenance.

The ideal candidate will apply scientific and analytical skills to drive process improvements, ensure regulatory compliance, and serve as a primary process