Production Documentation & Compliance Specialist III

ADP, Inc.; West Saint Paul (MN); Sur place; USD 75 000 - 85 000; Plein temps

Avantages offerts par ce poste

Equal Opportunity Employer

Résumé du poste

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

Responsabilités

• 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.

Connaissances

cGMP knowledge

GDP knowledge

Root cause analysis

Formation

Bachelor's degree preferred

Associate's degree with 6+ years cGMP experience

Outils

5 Whys

FMEA

Fishbone diagrams

Pareto charts

Description du poste

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Production Documentation & Compliance Specialist III

Full Time Professional West St. Paul, MN, US

3 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.