Production Documentation & Compliance Specialist III

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

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Production Documentation & Compliance Specialist III

Full Time Professional West St. Paul, MN, US

8 days ago Requisition ID: 1144

Salary Range: $75,000.00 To $85,000.00 Annually

About LTS:

LTS Lohmann Therapy Systems is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market.

At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter.

Job 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

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.

Equal Opportunity Employer: LTS Lohmann is an equal opportunity employer. We consider all qualified applicants for employment without regard to any characteristic protected by applicable federal, state, or local law.