Quality/Regulatory - Specialist, Quality Assurance {Portage, MI}

Matlen Silver, Inc.

Portage, MI

JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Communication Skills, Continuous Improvement, Contract Management, Cross-Functional, Detail Oriented, FDA (Food and Drug Administration), GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Healthcare, ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Medical Equipment, Operational Support, Operations Processes, Organizational Skills, Problem Solving Skills, Process Improvement, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis
LOCATION
Portage, MI
POSTED
10 days ago

Description

Quality Assurance Specialist (Contract) Location: Portage, MI

Contract Length: 12 Months to Start

Experience Required: Minimum 3 Years

Education: Bachelor's Degree Required

Position Overview We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This individual contributor role requires sound professional judgment, the ability to work independently with minimal supervision, and a strong understanding of quality systems, regulatory compliance, and process improvement.

The ideal candidate will have hands-on experience implementing quality standards, supporting audits and inspections, and ensuring compliance throughout all stages of operational and production processes.

Key Responsibilities

  • Implement and maintain quality standards across all stages of the process

  • Ensure compliance with internal procedures, regulatory requirements, and quality systems

  • Assess potential quality and compliance risks and provide recommendations for mitigation

  • Take ownership of quality control activities related to:

  • Laboratory studies

  • Clinical research

  • Testing and operations

  • Raw materials

  • Production processes

  • Finished products and services

  • Facilitate internal audits and regulatory inspections

  • Coordinate and support quality training initiatives

  • Apply professional expertise and independent judgment to resolve quality-related issues

  • Collaborate cross-functionally to drive continuous improvement and compliance excellence

Qualifications

  • Bachelor's degree required
  • Minimum of 3 years of relevant quality assurance or quality control experience
  • Strong understanding of quality systems, compliance standards, and regulated environments
  • Experience supporting audits and regulatory inspections
  • Ability to work independently with minimal supervision
  • Strong analytical, organizational, and communication skills
  • Practical knowledge gained through hands-on industry experience preferred

Preferred Skills

  • Experience in medical device, pharmaceutical, biotech, or healthcare environments
  • Familiarity with GMP, GLP, GCP, FDA, or ISO standards
  • Strong problem-solving and risk assessment capabilities

About the Company

M

Matlen Silver, Inc.