Deviations Investigation Specialist

Kindeva • Maryland Heights, MO

2d

About The Position

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Deviations Investigation Specialist partners with Operations, Quality, and cross-functional teams to investigate manufacturing and quality events, determine root cause, assess risk, and support the development of effective corrective and preventive actions. This role leads and facilitates deviation investigations, authors investigation records and risk assessments, and ensures investigations are completed accurately, objectively, and in compliance with applicable GMP and quality system requirements. The Deviations Investigation Specialist serves as a key resource in identifying systemic issues, improving compliance, and driving sustainable solutions that enhance product quality and manufacturing performance.

Requirements

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Quality, Business, or a related discipline; or equivalent combination of education and experience.
• 3+ years of experience in a GMP-regulated manufacturing environment.
• Experience authoring, investigating, reviewing, or approving deviations, investigations, or other quality system records.
• Experience with quality management systems and regulated documentation practices.
• Experience utilizing root cause analysis and structured problem-solving methodologies.
• Strong technical writing, analytical, and communication skills.
• Ability to effectively collaborate with cross-functional teams and influence outcomes.

Nice To Haves

• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience supporting aseptic processing, sterile fill-finish, visual inspection, packaging, or device manufacturing operations.
• Experience authoring or supporting risk assessments, CAPAs, change controls, and effectiveness checks.
• Experience participating in regulatory inspections, customer audits, or internal audits.
• Lean Six Sigma Green Belt, Black Belt, ASQ certification, or similar quality-related credential.
• Experience within a CDMO environment.

Responsibilities

• Lead deviation investigations related to manufacturing and operational events, ensuring timely completion and compliance with site quality systems and GMP requirements.
• Partner with Operations, Quality, Engineering, Validation, and other stakeholders to gather facts, assess impact, establish containment actions, and determine appropriate response plans.
• Facilitate root cause investigations using structured problem-solving methodologies and data-driven analysis to identify the most probable causes of events.
• Perform and document risk assessments to evaluate product quality, regulatory, operational, and business impacts.
• Author clear, thorough, and technically sound investigation reports, ensuring conclusions are supported by facts, evidence, and data.
• Develop and support corrective and preventive actions (CAPAs) that appropriately address root causes and reduce recurrence.
• Author or support quality system documentation including deviations, CAPAs, risk assessments, change controls, effectiveness checks, and related records as required.
• Analyze investigation data and trends to identify recurring issues and opportunities for continuous improvement.
• Support training, coaching, and collaboration efforts to improve investigation quality, problem-solving capabilities, and compliance across the organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level