Quality Assurance Specialist
Job Description
Job Description
A-Line Staffing is now hiring Quality Assurance Specialist – Columbus, NE
please contact Marcia Hamilton at (586) 710-7979 or mhamilton@alinestaffing.com
Quality Assurance
Location: Columbus, NE
Pay Rate: $31.00/hour
Work Type: Onsite | Full-time
Contract Type: Contract (potential for extension or hire)
We’re seeking a detail-oriented Quality Assurance Specialist (Spec 3) to join our client's quality team in Columbus, NE. This role is critical to ensuring product integrity, investigating customer complaints, and maintaining compliance with GMP and ISO standards. Ideal candidates bring strong analytical, technical writing, and root cause investigation skills.
Key Responsibilities
- Investigate, prioritize, and resolve customer complaints in a timely manner.
- Evaluate complaints against quality criteria and determine investigation paths.
- Perform root cause analysis and implement effective corrective/preventive actions (CAPAs).
- Review batch records, change control documentation, and quality trend data.
- Author clear, data-driven technical investigation reports.
- Partner with other Quality Specialists to ensure investigations meet internal timelines.
- Maintain adherence to quality systems, SOPs, and regulatory requirements (cGMP, ISO).
- Support continuous improvement efforts within quality systems.
Required Qualifications
- High School Diploma or GED.
- 1–3 years of experience in a GMP-regulated environment.
- Strong skills in:
-
- Statistical and analytical problem-solving
- Technical writing and communication
- Quality systems knowledge (GMPs and ISO standards)
Preferred Qualifications
- Bachelor’s Degree in Engineering, Science, or related field.
- Experience in pharmaceutical or medical device industries.
- Proficiency in root cause investigation tools (e.g., 5 Whys, Fishbone Diagrams, CAPA).
A-Line Staffing is now hiring Quality Assurance Specialist – Columbus, NE
contact Marcia Hamilton at (586) 710-7979 or mhamilton@alinestaffing.com