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Quality Assurance Specialist

Nacogdoches, TX · On-site

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Computer literate with strong MS Excel skills and the ability to learn specialized databases and ... A Valid Driver's License Additional Skills/Knowledge Career Team Would Love for This Role

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Must Haves: Experience with validation systems critical IQ, PQ, OQ GxP Principles 21 CFR Pt 11 ... computer sciences or similar vocations generally obtained through completion of a four-year ...

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As of Sep 9, 2026, the average hourly pay for computer system validation qa specialist in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

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Infographic showing various Computer System Validation Qa Specialist job openings in the United States as of June 2026, with employment types broken down into 9% As Needed, 48% Full Time, 37% Part Time, 4% Temporary, and 2% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Quality Assurance Specialist

West Saint Paul, MN • On-site

LTS Lohmann Therapy
See more jobs at LTS Lohmann Therapyexternal

$65K - $75K/yr

Full-time

Posted 29 days ago

Job description


Job Title: Quality Assurance Specialist II

Department/Division: Quality Assurance

Reports to: Director, Product Quality Operations


 

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 2,000 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.


Job Summary

Lohmann Therapy Systems North America is seeking a talented Quality Assurance Specialist who will play a crucial role in ensuring the integrity of our quality systems and processes. Your responsibilities will include reviewing operations documentation, managing non-conformance and CAPA systems, and supporting various quality assurance functions.

This is a full-time, on-site role located in West St. Paul, MN.

  • Shift hours 9:30am-6:00pm (some flexibility); Monday - Friday

What You Will Do:

  • Review batch records, operations documentation, and other relevant documents to ensure compliance with cGMP, ISO 13485, EU, FDA regulations, LTS procedures, and customer needs.
  • Investigate and resolve discrepancies in manufacturing documentation.
  • Communicate with customers to address their concerns and ensure timely product release. (Complaint investigations).
  • Implement and manage LTS's Non-conformance and CAPA system.
  • Support the Material Review Board in resolving non-conformances, customer complaints, and implementing corrective actions.
  • Provide cross-functional support to Quality, Engineering, Operations, and Purchasing on investigations and corrective action reports.
  • Initiate and write investigation reports for MRRs and Incidents.
  • Utilize effective CAPA and Root Cause Analysis tools during investigations.
  • Provide training and support to colleagues on quality assurance procedures and systems.
  • Back up other Quality Assurance Specialists and Documentation Specialists as needed.
  • Author/revise SOPs related to Quality Assurance processes.
  • Participate in various projects to meet LTS and customer quality requirements.

 

Your Background:

  • 2-year technical degree required; 4-year technical degree preferred.
  • 2-5 years of Quality Assurance/Quality Control experience in a manufacturing environment, preferably in the medical device or pharmaceutical industry.
  • 2-5 years of experience working in a cGMP regulated environment.
  • 2+ years experience handling complaint investigations

Preferred Skills/Abilities:

  • Strong ability to work independently and manage multiple projects simultaneously.
  • Excellent attention to detail and accuracy.
  • Knowledge of cGMP, 21 CFR 210, 211, 820, ISO 13485, and other FDA regulations.
  • Proficiency in MS Office Suite and applicable QMS software.
  • Effective written and verbal communication skills.
  • Ability to train and coach others.
  • Strong problem-solving and analytical skills.

We Offer

  • Competitive compensation and benefits package
  • Opportunities for professional growth and development
  • A collaborative and supportive work environment
  • The chance to contribute to improving patient lives

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.