Onsite GMP Compliance Specialist – Production Documentation

LTS Lohmann Therapy; West Saint Paul (MN); On-site; USD 75,000 - 85,000; Full time

Job summary

LTS Lohmann Therapy Systems is seeking a Production Documentation & Compliance Specialist III to ensure compliant, efficient manufacturing. You will review batch records, strengthen processes, lead investigations, and collaborate with Production, Quality and Engineering to meet cGMP and GDP standards.

This role offers on-site West St. Paul, MN duties with regular daytime hours. You’ll contribute to continuous improvement, document control, and CAPA execution in a dynamic production environment.

Qualifications

• At least 6 years in a cGMP manufacturing environment in documentation or compliance.
• At least 4 years using root cause analysis tools (5 Whys, FMEA, fishbone, Pareto).
• Bachelor's degree preferred; alternate with 6+ years cGMP or 10+ years experience.
• Excellent verbal and written communication skills.

Responsibilities

• Review production batch records for completeness, accuracy and cGMP/GDP compliance.
• Capture metrics, identify non-conformances and report findings.
• Revise master batch records, SOPs and docs to improve clarity and alignment.
• Input on design of pre-commercial batch records.
• Provide informal leadership on the production floor to support policies.
• Coordinate investigations into non-conformances and CAPAs with Production & Quality.
• Apply root cause analysis to investigate issues and drive CAPA closure.
• Participate in Continuous Improvement and 5S initiatives.
• Build collaborative relationships across Production, Quality, and Engineering.

Skills

Root cause analysis

cGMP & GDP knowledge

Verbal & written communication

Education

Bachelor's degree preferred

Associate degree + 6+ yrs cGMP experience

10+ yrs cGMP manufacturing experience

Job description

LTS Lohmann Therapy Systems is seeking a Production Documentation & Compliance Specialist III to ensure compliant, efficient manufacturing. You will review batch records, strengthen processes, lead investigations, and collaborate with Production, Quality and Engineering to meet cGMP and GDP standards.

This role offers on-site West St. Paul, MN duties with regular daytime hours. You’ll contribute to continuous improvement, document control, and CAPA execution in a dynamic production environment.