Job Description
Deviation InvestigatorConcord, North CarolinaContract to Hire $35-45/hr Position Overview The Deviation Investigator is responsible for leading and supporting investigations related to manufacturing, laboratory, and quality deviations within a GMP-regulated pharmaceutical environment.This role ensures deviations are thoroughly investigated, root causes are identified, and effective corrective and preventive actions (CAPA) are implemented to maintain compliance with regulatory standards and internal quality systems.The investigator works cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and Technical Operations to resolve issues and drive continuous improvement across the manufacturing process.Key Responsibilities Lead and conduct deviation investigations related to manufacturing processes, equipment, laboratory results, and quality systems.Perform root cause analysis using structured methodologies such as fishbone diagrams, 5-Why analysis, and fault tree analysis.Develop, implement, and track Corrective and Preventive Actions (CAPA) to ensure sustainable resolution of issues.Author and review investigation reports to ensure they meet internal quality standards and regulatory expectations.Collaborate with Manufacturing, Engineering, and Quality teams to determine technical root causes and process improvements.Ensure deviations and investigations are completed within required timelines and comply with Good Manufacturing Practices (GMP).Support regulatory inspections and internal audits by providing documentation and investigation summaries.Identify systemic trends across deviations and recommend process improvements to prevent recurrence.Maintain accurate documentation within electronic quality systems such as TrackWise, Veeva, or similar platforms.Basic Qualifications Bachelor's degree in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related scientific field 2-5years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments Experience conducting deviation investigations or quality events in a GMP environment Strong understanding of FDA, cGMP, and regulatory compliance requirements Preferred Qualifications Experience with CAPA management and root cause analysis methodologies Familiarity with quality management systems (QMS) such as TrackWise, Veeva, or MasterControl Experience supporting manufacturing, laboratory, or technical operations investigations Strong technical writing and documentation skills Ability to manage multiple investigations simultaneously while meeting strict timelines Key Skills Root Cause Analysis Deviation Investigation CAPA Development GMP Compliance Technical Writing Cross-Functional Collaboration Problem Solving and Critical Thinking Work Environment Pharmaceutical manufacturing and quality environment Collaboration with cross-functional teams including Quality, Engineering, Manufacturing, and Regulatory Hybrid office/manufacturing floor environment depending on investigation requirements Disclaimer:Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC.All employees receive the same benefits, policies, and terms of employment.EEO:We are committed to creating an inclusive environment for all employees and applicants.We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.Benefits & Perks:Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs.We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays.We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.Pay Disclaimer:The pay range for this job level is a general guideline only and not a guarantee of compensation or salary.Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.Job Type:Contract Pay:$35.00 - $45.00 per hour Expected hours:40 per week Benefits:Dental insurance Health insurance Vision insurance Application Question(s):Are you local to Concord, North Carolina? Do you have experience in a fast-paced manufacturing environment involving deviations? Are you comfortable with a contract