Astrix · 1 day ago
QA Specialist III
Springfield, MO
Full-time
Onsite
Senior Level, Lead/Staff
$45/hr - $47/hr
10+ years expAstrix is a leading global CDMO, and they are seeking a QC Deviation Specialist III to join their growing team in Greene County, Missouri. This role involves leading and executing quality investigations, ensuring compliance with internal procedures and regulatory requirements while driving continuous improvement through effective root cause analysis and implementation of corrective actions.
ConsultingInformation Technology
Responsibilities
Perform and document Deviation Investigations for Manufacturing and Quality Control operations
Conduct Root Cause Analyses (RCA) and determine appropriate Corrective and Preventive Actions (CAPAs) to address identified issues
Partner with Manufacturing, QC, and Quality Assurance teams to support investigations and ensure timely and compliant closure
Provide coaching and training to staff on deviation investigations, RCA methodologies, and investigator qualification
Perform and draft Out-of-Specification (OOS) investigations in accordance with internal policies and regulatory standards
Review and analyze data to identify trends, recurring issues, and opportunities for process improvement
Support continuous improvement initiatives within the Quality Management System (QMS)
Ensure all activities comply with applicable GMP, ISO, and regulatory requirements
Qualification
Required
Minimum 10 years of relevant experience in Quality Systems Management, with direct experience in manufacturing and quality control deviation management
Strong knowledge of Root Cause Analysis (RCA) and CAPA development and implementation
Proven experience writing and managing quality investigations in a regulated industry (e.g., pharmaceutical, biotechnology, medical device, or similar)
Bachelor's degree preferred in a scientific, engineering, or related technical discipline
Excellent analytical, problem-solving, and communication skills
Ability to work independently and collaboratively in a cross-functional team environment
Preferred
Familiarity with Good Manufacturing Practices (GMP) and regulatory guidance (e.g., FDA, EMA, ICH)
Experience using electronic quality systems (e.g., TrackWise, Veeva Vault, or similar)
Prior experience mentoring or training personnel on deviation and CAPA processes
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
H1B Sponsorship
Astrix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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