Documentation and Compliance Specialist - Manufacturing

About LTS:

LTS Lohmann is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes.

We Care.

We Create.

We Deliver.

No agencies please!

Job Summary

Are you a detail-oriented individual with a strong understanding of cGMPs and a passion for ensuring quality in pharmaceutical manufacturing? LTS Lohmann is seeking a motivated Production Documentation & Compliance Specialist to support our production activities through meticulous documentation review and proactive compliance initiatives.

In this role, you will be instrumental in maintaining our high standards of Good Manufacturing Practices (cGMP) by reviewing executed batch records, providing informal leadership on the production floor, leading root cause investigations for production-related non-conformances, and contributing to the clarity and simplicity of our master batch records. This is an excellent opportunity to contribute to a dynamic and growing organization committed to excellence in drug delivery.

This is a full time, onsite/hybrid role located in West St. Paul MN.

• Business hours: 8:00am- 5:00pm; Monday - Friday
• Hybrid potential after initial probationally period, up to 2 days/week

What You Will Do:

Batch Record Review & Documentation:

• Thoroughly review executed batch records for completeness, accuracy, and adherence to LTS good documentation practices and cGMP regulations.
• Capture and report relevant quality metrics as assigned.
• Revise existing commercial master batch records to enhance clarity and ease of use.
• Provide valuable input on the design of pre-commercial batch records.
• Update existing Standard Operating Procedures (SOPs) and supporting documentation to align with commercial batch record activities.

Process Improvement & Compliance:

• Identify and implement improvements to processes that support manufacturing activities.
• Conduct GEMBA walks on the production floor to ensure consistent adherence to cGMP principles and company policies.
• Participate in Continuous Improvement initiatives as assigned.
• Support and actively engage in 5S initiatives to maintain an organized and efficient work environment.

Non-Conformance & CAPA Management:

• Conduct and collaborate on investigations for production-related Non-Conformances (NCR) and Corrective and Preventative Actions (CAPA) in coordination with Production Management and Quality.
• Initiate NCRs identified during the executed batch record review process within the LTS Quality Management System (QMS).
• Utilize appropriate investigative tools to perform or contribute to thorough root cause analysis.
• Ensure the timely identification and completion of effective corrective and preventative actions.
• Cultivate collaborative relationships with key stakeholders across departments.

Qualifications:

• Bachelor’s degree with 3 years of relevant experience working in a cGMP manufacturing environment.
• OR Associate’s degree with 5 years of relevant experience working in a cGMP manufacturing environment.
• Sound understanding of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs) within regulated industries, preferably pharmaceutical or medical device.
• Proven experience in utilizing necessary investigative tools for effective root cause analysis.
• Excellent verbal and written communication skills, with the ability to clearly and concisely convey information.

Preferred Qualifications:

• A degree in a science or engineering-related field is preferred.

If this sounds like you, we want to hear from you!

LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.