Production Documentation & Compliance Specialist III
LTS Lohmann Therapy
Summary
Join LTS Lohmann as an experienced Production Documentation and Compliance Specialist to play a key role in supporting compliant, efficient manufacturing operations. In this position, you will review production documentation, strengthen processes, lead investigations, and collaborate across Production, Quality, and Engineering to help ensure our work meets current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). This is an opportunity for an experienced documentation and compliance professional to provide informal leadership on the production floor, improve commercial batch records, support continuous improvement, and help resolve production-related non-conformances through effective root cause analysis and corrective and preventive actions. This is a full-time, onsite role located in West St. Paul, MN. Working hours are 8:00a – 4:30pm
Job description
What You’ll Do
- Review executed batch records for completeness, accuracy, and compliance with cGMP and LTS good documentation practices.
- Capture and report assigned metrics and identify non-conformances discovered during batch record review.
- Revise commercial master batch records, SOPs, and supporting documentation to improve clarity, simplicity, and alignment with manufacturing activities.
- Provide input on the design of pre-commercial batch records.
- Provide informal leadership on the production floor to support adherence to company policies and procedures.
- Coordinate with Production Management and Quality to conduct investigations into production-related non-conformances and CAPAs.
- Use root cause analysis tools to investigate issues and help ensure corrective and preventive actions are identified and completed on time.
- Participate in Continuous Improvement and 5S initiatives.
- Build collaborative relationships across Production, Quality, and Engineering.
What You Bring
- A strong understanding of cGMP and GDP requirements in a regulated industry such as pharmaceuticals or medical devices.
- At least 6 years of experience in a cGMP manufacturing environment in a production documentation or compliance role; experience in a regulated pharmaceutical or medical device company is strongly preferred.
- At least 4 years of demonstrated experience using investigative root cause analysis tools, such as 5 Whys, FMEA, fishbone diagrams, or Pareto charts.
- Excellent verbal and written communication skills.
- A bachelor’s degree is preferred. An associate’s degree may be considered with at least 6 years of cGMP manufacturing experience, or candidates may qualify with at least 10 years of cGMP manufacturing experience. A degree in a science- or engineering-related field is preferred.
Requirements
- A strong understanding of cGMP and GDP requirements in a regulated industry such as pharmaceuticals or medical devices.
- At least 6 years of experience in a cGMP manufacturing environment in a production documentation or compliance role.
- At least 4 years of demonstrated experience using investigative root cause analysis tools, such as 5 Whys, FMEA, fishbone diagrams, or Pareto charts.
- Excellent verbal and written communication skills.
- A bachelor’s degree is preferred.
- An associate’s degree may be considered with at least 6 years of cGMP manufacturing experience, or candidates may qualify with at least 10 years of cGMP manufacturing experience.
- A degree in a science- or engineering-related field is preferred.
Company overview
LTS Lohmann Therapy Systems is a global leader in innovative drug delivery solutions and a premier Contract Development and Manufacturing Organization (CDMO). Founded in 1984, the company specializes in developing and manufacturing transdermal therapeutic systems (TTS), oral thin films (OTF), and micro array patches (MAP). With over 1,500 employees across five global sites in the US, Germany, Israel, and a representative office in China, LTS has pioneered numerous medical breakthroughs including the first nicotine patch, first contraceptive patch, first Parkinson's patch, and first oral active ingredient film. The company operates with a patient-centric philosophy encapsulated in its purpose statement: 'We CARE. We CREATE. We DELIVER.' LTS serves as a dedicated technology partner to pharmaceutical companies, offering end-to-end development and manufacturing services without competing in drug development. With over 40 commercial products and 50+ active development programs, the company combines deep expertise with patient-centric innovation to advance small molecules, biologics, and vaccines through non-invasive delivery technologies.