Deviation Investigator

Deviation Investigator at Medasource Deviation Investigator at Medasource in Concord, North Carolina Posted in 1 day ago.

Type:

full-time

Job Description:

Title:

Deviation Investigation Writer /

Associate Location:

Concord, NC Duration:

6 month contract (potential of extension or conversion) Summary We are seeking a detail-oriented and technically skilled Deviation Investigator to support PAR Operations. This role is responsible for conducting thorough investigations into deviations, identifying root causes, coordinating CAPA activities, and authoring clear, technically accurate documentation. The ideal candidate is analytical, an excellent communicator, and capable of managing multiple quality system activities while ensuring compliance with GMP and regulatory expectations. Key Responsibilities

• Conduct comprehensive investigations into deviations, determining root causes and contributing factors.
• Write clear, concise, and well-structured technical deviation reports.
• Develop, support, and track Corrective and Preventive Actions (CAPAs) through completion.
• Follow up with CAPA owners to ensure timely execution and closure of assigned actions.
• Collaborate cross-functionally with Operations, Quality, Engineering, and other stakeholders to gather information and support investigations.
• Apply critical thinking and technical expertise to evaluate issues and recommend effective CAPAs.
• Assist with procedure updates, revisions, and controlled document maintenance as needed.
• Track and maintain quality metrics, investigation metrics, and CAPA-related performance indicators.
• Maintain strict compliance with internal procedures, documentation standards, and regulatory expectations.
• Periodically gown and enter classified GMP manufacturing areas to observe operations, gather information, interview personnel, and support investigations firsthand. Required Qualifications
• Proven ability to write technical documentation, investigations, or structured reports.
• Strong analytical skills and exceptional attention to detail.
• Ability to assess, interpret, and communicate technical issues clearly.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Proficiency in Microsoft Office Suite or similar tools.
• Ability and willingness to gown and work within classified GMP manufacturing environments when required. Preferred Qualifications
• Academic or professional background in Engineering, Life Sciences, Quality Assurance, or a related technical field.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience conducting deviation investigations and managing CAPAs.
• Experience updating SOPs, work instructions, and controlled GMP documentation.
• Experience tracking and reporting quality metrics.
• Familiarity with quality management systems such as Veeva, TrackWise, MasterControl, or similar platforms.
• Understanding of GMP manufacturing operations and regulatory requirements. Additional Information
• Dynamic, collaborative work environment with opportunities to support continuous improvement initiatives.
• Position combines technical writing, investigation ownership, CAPA coordination, procedural updates, and quality metric tracking.
• While much of the role is desk-based, periodic entry into GMP manufacturing areas is required to support investigations and gain firsthand understanding of events.
• Full training and onboarding will be provided to support success in the role.
• Candidates without direct pharmaceutical experience are encouraged to apply if they possess strong technical writing, investigation, and analytical skills.