POSITION SUMMARY:

The QA Investigation Specialist is responsible for managing, implementing, and coordinating the investigations program to ensure all deviations and quality events are thoroughly investigated. This role focuses on determining root causes and implementing corrective and preventive actions (CAPAs) to improve compliance and reduce recurrence of quality issues.
Key Responsibilities:
Assign, track, and monitor all investigations, CAPAs, effectiveness checks (ECs), and customer complaints for the Decatur site.
Collaborate with cross-functional teams to perform comprehensive investigations and develop effective CAPAs.
Provide subject matter expertise and guidance to investigators to ensure compliance with regulatory requirements.
Review and evaluate the quality of investigations, CAPAs, ECs, and complaints to ensure completeness, accuracy, and regulatory adherence.
Coordinate investigation priorities and timelines to ensure timely closures.
Support regulatory inspections, internal audits, and customer audits as required.
Qualifications & Experience:
Bachelor’s degree in a relevant field required.
Minimum of 4–6 years of experience in Quality Assurance with a focus on investigations, CAPAs, ECs, and customer complaints.
Proven experience in cGMP training and implementation.
Solid understanding of FDA regulations, including 21 CFR Parts 11, 210, 211, and 820, as well as United States Pharmacopeia standards.
Job Requirements:
Availability to work a standard 40-hour workweek, with flexibility for additional hours as needed to meet deadlines.
Strong knowledge of cGMP and regulatory expectations.
High level of organizational, analytical, and communication skills.
Physical & Mental Demands:
Physical:
Regularly required to sit, stand, walk, talk, hear, and use hands for handling or feeling.
Vision abilities include close vision for computer and written documentation work.
Mental:
Ability to write and comprehend technical documentation.
Capable of multitasking and working independently in a fast-paced, deadline-driven environment.
Strong analytical and deductive reasoning skills.
Ability to maintain confidentiality and professionalism under pressure.
Safety Requirements:
Use of safety glasses, close-toed shoes, and latex gloves required in designated areas within the facility.