Senior cGMP Documentation & Compliance Specialist

ADP, Inc.; West Saint Paul (MN); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

LTS Lohmann Therapy Systems, a global leader in transdermal and oral film drug delivery, seeks a Production Documentation & Compliance Specialist III in West St. Paul, MN.

You will review production records, strengthen processes, lead investigations, and drive CAPAs to ensure adherence to cGMP and GDP principles. You’ll collaborate with Production, Quality, and Engineering, providing informal leadership on the floor and contributing to continuous improvement and 5S initiatives.

Qualifications

• 6+ years in a cGMP manufacturing environment in a documentation/compliance role
• Experience using investigative root cause analysis tools (5 Whys, FMEA, fishbone diagrams, Pareto)
• Bachelor's degree preferred; associate with ≥6 years or ≥10 years of cGMP manufacturing experience

Responsibilities

• Review batch records for completeness, accuracy, and cGMP/GDP compliance.
• Capture metrics and identify non-conformances during batch record review.
• Revise master batch records, SOPs, and supporting docs for clarity and alignment with manufacturing activities.
• Provide input on design of pre-commercial batch records.
• Provide informal leadership on the production floor to support policy adherence.
• Coordinate with Production Management and Quality to investigate non-conformances and CAPAs.
• Apply root cause tools to ensure timely corrective and preventive actions.
• Participate in Continuous Improvement and 5S initiatives.
• Build collaborations across Production, Quality, and Engineering.

Skills

cGMP knowledge

GDP knowledge

Root cause analysis

Education

Bachelor's degree preferred

Associate's degree with 6+ years cGMP experience

Tools

5 Whys

FMEA

Fishbone diagrams

Pareto charts

Job description

LTS Lohmann Therapy Systems, a global leader in transdermal and oral film drug delivery, seeks a Production Documentation & Compliance Specialist III in West St. Paul, MN.

You will review production records, strengthen processes, lead investigations, and drive CAPAs to ensure adherence to cGMP and GDP principles. You’ll collaborate with Production, Quality, and Engineering, providing informal leadership on the floor and contributing to continuous improvement and 5S initiatives.