Quality Assurance Specialist

LTS Lohmann Therapie-Systeme AG; Saint Paul (MN); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Growth opportunities

Collaborative work environment

Impactful patient outcomes

Job summary

LTS Lohmann Therapie-Systeme AG is seeking a Quality Assurance Specialist II for our West St. Paul, MN site.

You will ensure the integrity of quality systems, review operations documents, and manage non-conformance and CAPA, supporting various QA functions to meet customer and regulatory expectations. This full-time, on-site role requires 2-5 years QA/QC in manufacturing and a 2-year technical degree (4-year preferred).

Qualifications

• 2-year technical degree required.
• 2-5 years QA/QC experience in a manufacturing environment.
• 2-5 years experience in a cGMP regulated environment.
• 2+ years experience handling complaint investigations.

Responsibilities

• Review batch records and documentation for compliance with cGMP, ISO 13485, FDA regulations.
• Investigate discrepancies in manufacturing documentation and implement corrective actions.
• Communicate with customers to address 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 and customer complaints.
• Provide cross-functional QA support to Engineering, Operations, and Purchasing on investigations.
• Initiate and write investigation reports for MRRs and Incidents.
• Utilize CAPA and Root Cause Analysis tools during investigations.
• Provide training and back-up support to QA and Documentation Specialists.
• Author/revise SOPs related to Quality Assurance processes.
• Participate in projects to meet quality requirements.

Skills

Quality Assurance

Attention to detail

Cross-functional collaboration

Documentation

Problem-solving

Education

2-year technical degree

4-year technical degree preferred

Tools

MS Office Suite

QMS software

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Assurance Specialist

Full Time Professional West St. Paul, MN, US

20 days ago Requisition ID: 1131

Salary Range: $65,000.00 To $75,000.00 Annually

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.