Fda Regulatory Entrylevel Jobs in Minnesota (NOW HIRING)

Team : Quality

History:

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

WHY THIS ROLE MATTERS

This role is responsible for maintaining the document control system and coordinating product and packaging labeling activities in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and applicable company procedures. This is an entry-level position well-suited for a detail-oriented individual seeking to build a career in quality systems.

The Quality Documentation and Labeling Associate supports ProMed's mission and values by applying and reinforcing the company's brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

WHAT YOU’LL ACHIEVE

As the Quality Documentation and Labeling Associate, you'll ensure that ProMed's controlled documents and product labeling remain accurate, current, and fully compliant with cGMP and FDA requirements — giving Operations, Regulatory Affairs, and Marketing a reliable system to work from and giving auditors clear evidence of control. This is achieved through the following groups of tasks:

Document Control

• Issue, distribute, and archive controlled documents including SOPs, work instructions, batch records, and quality forms in accordance with the document control procedure.
• Process document change control requests, track revision history, and ensure documents are reviewed and approved by appropriate stakeholders within established timelines.
• Maintain the document management system to ensure accuracy, accessibility, and version integrity of all controlled documents.
• Conduct periodic document reviews and notify document owners of upcoming expiration dates.
• Support internal and external audits by retrieving controlled documents and demonstrating compliance with document control procedures.

Labeling

• Coordinate the creation, review, revision, and approval of product labels and packaging artwork in compliance with FDA 21 CFR and applicable regulatory requirements.
• Maintain labeling master files and ensure that only current, approved label versions are released for use.
• Perform label reconciliation activities and support the investigation of labeling discrepancies or errors.
• Collaborate with Operations, Regulatory Affairs, and Marketing to ensure label content accuracy prior to printing and distribution.
• Assist with label change management activities resulting from formulation, regulatory, or branding updates.

Other Responsibilities

• Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager.
• Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities.
• Support the implementation of regulatory changes and quality system improvements as directed.
• Assist in preparing responses to audit observations or regulatory findings that involve document or records management.
• Input data to create and revise material and method masters in the ERP system.

 Necessary Skills:

• Experience in quality documentation and/or learning management systems.
• Strong interpersonal, written, and verbal communication skills.
• Ability to establish collaborative relationships with various departments to deliver on quality commitments.
• Strong computer skills, including Microsoft Word and quality systems software.
• Attention to detail and commitment to data integrity and accuracy in all quality records.
• Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements.

Minimum Qualifications For The Role:

• High School Diploma or GED.
• 2+ years of work experience in quality or document control.
• Must be very detail-oriented and accurate with data entry.
• Speaks and reads English fluently.

Physical, Sensory, Cognitive & Neurological Demands:

• Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, reaching, lifting, pushing, pulling, and repetitive movements throughout the workday.
• Exposure to heated/air-conditioned, ventilated facilities with fluorescent lighting.
• Exposure to a building where a variety of chemical substances are used for cleaning and/or operation of equipment.
• The noise level in the work environment is usually minor.
• Duties are performed indoors.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

HOW YOUR SUCCESS WILL BE MEASURED

Your Key Performance Indicators: 

• Timely processing of document change control requests within established turnaround times.
• Accuracy and completeness of controlled document issuance, distribution, and archiving.
• On-time completion of periodic document reviews and expiration notifications.
• Label reconciliation accuracy and timely resolution of labeling discrepancies.
• Audit readiness, measured by successful and timely retrieval of controlled documents during internal and external audits.

ProMed offers a generous benefits package including:

• 401k with company match
• Profit Sharing Program
• Medical Insurance
• Health Savings Account/Flexible Spending Account
• Dental Insurance
• Vision Insurance
• Life Insurance
• Paid Family Medical Leave and Long-Term Disability Insurance
• Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
• Pet Insurance

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.