Quality Assurance Deviations Associate

The QA Deviations Associate will oversee the investigation, documentation, oversight, and resolution of deviations to ensure compliance with regulatory standards, internal policies, and industry best practices.  The ideal candidate will bring expertise in deviation investigations for CGMP manufacturing and testing, an understanding of chemical processes for intermediates and APIs, a proactive problem-solving mindset, a coaching mindset, and a commitment to maintaining the highest standards of product quality and safety.  This role is both a hands-on role and an oversight role for deviations.  

Core Responsibilities: 

• Provide oversight on open deviation records and ensure owners are progressing and closing on time as defined by site procedures. 
• Ensure consistent quality of investigation records, root cause investigation, report writing, and CAPA/Effectiveness Check development for deviations in collaboration with cross-functional teams. 
• Draft, review, and approve deviation reports, ensuring accuracy, completeness, and compliance with Current Good Manufacturing Practices (CGMP) and other applicable regulations (e.g., FDA, EMA). 
• Develop and implement corrective and preventive actions (CAPAs) to address identified issues and mitigate recurrence. 
• Provide guidance and training to QA team members and operational staff on deviation management processes. 
• Lead the Deviation and CAPA board to routinely monitor the status of open deviations and CAPAs.   
• Maintain and update deviation tracking systems, ensuring timely closure of investigations and documentation. 
• Collaborate with manufacturing, engineering, and quality control teams to identify trends and recommend process improvements. 
• Present a review of deviation root cause trends and system metrics for Management Review meetings at the site and corporate level. 
• Support internal and external audits by preparing deviation-related documentation and participating in audit responses. 
• Ensure all activities align with company SOPs, regulatory requirements, and quality objectives.
• Aid in the harmonization and maintenance of harmonization of the Quality Management Systems for deviations across sites, updating procedures, decision trees and compliance tools for the site, as needed. 
• Participate in FDA inspections, audits, and inspections or in client audits as needed as an SME for the Quality System for deviations.
• Educate staff on best practices, including new hire quality orientation and compliance training.
• Other duties as assigned.

Qualifications:

Required

• Bachelor’s degree in a scientific or technical field (e.g., Biology, Chemistry, Engineering) or equivalent experience. 
• 3+ years of experience with deviation management in a regulated industry (pharmaceuticals, biotech, or medical devices preferred). 
• In-depth knowledge of CGMP, ICH guidelines, and regulatory standards (e.g., 21 CFR Part 11, ISO 13485) governing deviations. 
• Proven experience leading complex investigations and writing detailed technical reports. 
• Strong analytical skills and proficiency with root cause analysis tools (e.g., 6M, 5 Whys, Fishbone). 
• Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented environment. 
• Excellent technical writing skills and the ability to clearly express ideas in English.
• Proficiency in quality management software (e.g., TrackWise, Veeva, MasterControl).
• Able to successfully interface with internal and external customers.
• Ability to work independently and in a team environment.
• Experience with Microsoft Office applications, including Word, Excel and PowerPoint at a minimum. 

Preferred

• Certification as a Deviation Investigator/Reviewer
• Experience creating metrics for driving continuous improvement
• Experience working in drug substance manufacturing