QA Investigator I

Jost Chemical Co Inc • Overland, MO

3d

About The Position

The Quality Investigator works under the general supervision of the Quality Assurance Compliance Supervisor in a cGMP‑regulated manufacturing environment operating under ICH Q7A standards. This role supports the implementation, maintenance, and continuous improvement of the Quality Assurance system through investigation and resolution of deviations, failures, and customer complaints. Employees in this role demonstrate competence in managing low‑complexity deviations and associated CAPAs.

Requirements

• High School Diploma required with 1–2 years of direct experience conducting investigations, root cause analysis, and executing CAPAs in an FDA‑regulated environment OR Bachelor of Science degree in Chemical Engineering, Chemistry, Biochemistry, or related field, with no prior investigation experience required
• cGMP regulations, ICH guidelines, pharmaceutical compendia, and FDA expectations
• Root cause analysis tools and investigation methodologies
• Basic mathematics
• Microsoft Office applications (broad proficiency)
• Strong critical thinking, analytical reasoning, and problem‑solving abilities
• Strong technical writing skills and ability to clearly document complex issues
• High attention to detail in data processing and documentation
• Ability to manage multiple projects simultaneously
• Effective collaboration in a team environment
• Ability to adapt to changing priorities and demands
• Communicate effectively, both verbally and in writing
• Review, compile, and verify technical data and documentation
• Accurately identify, gather, analyze, and record data
• Adhere to customer, organizational, and regulatory requirements
• Work effectively in a fast‑paced environment while meeting productivity expectations
• Present issues, trends, and investigation outcomes clearly using technical and concise language

Responsibilities

• Initiate, track, trend, lead, write, and close investigations related to internal failures and external customer complaints
• Drive timely completion of corrective and preventive actions (CAPAs)
• Assist department subject matter experts with root cause analysis
• Conduct personnel interviews to determine the sequence of events during investigations
• Review chemical test data as part of investigative activities
• Develop investigation SOPs and work instructions; support training as needed
• Ensure proper verification of effectiveness for CAPAs
• Maintain and analyze trends within the CAPA database
• Collaborate cross‑functionally with Production, Packaging, Engineering, Quality Assurance, Quality Control, and Maintenance teams to ensure timely closure of investigations
• Escalate actions as needed when investigation or CAPA deadlines approach
• Participate in daily quality meetings to provide status updates and identify trends
• Participate in cross‑functional meetings related to failures and deviations
• Assist with weekly reporting of open investigations and ensure timely completion
• Assist with monthly reporting of failure metrics and investigation trends
• Perform other duties as assigned

Benefits

• Shift differential for production, maintenance, and laboratory employees
• Medical, Dental, and Vision Insurance, plus Short‑ and Long‑Term Disability and Life Insurance
• 401(k) plan with safe‑harbor contribution
• Paid Time Off (PTO) available from day one
• Nine company‑paid holidays (72 hours annually)
• Uniforms provided for applicable roles
• Annual footwear allowance for laboratory, maintenance, and production employees
• 24/7 access to our free on‑site fitness center
• On‑the‑job training and professional development opportunities to support growth in Quality Assurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 101-250 employees