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Technical Investigation Writer in Morrisville, NC at APEX Systems

Date Posted: 5/17/2019

Job Snapshot

Job Description

Job #:  971629


Apex Systems is seeking qualified candidates for a Sr. Technical Investigation Writer for large Contract Research Organization in RTP!
 
Sr. Technical Investigation Writer 


The position is responsible for leading investigation activities, identifying root cause failure modes, developing failure specific Corrective and Preventative Actions (CAPAs), and writing deviation investigation reports supporting non-conforming (process and procedural) events. To be successful, this individual effectively leverages key investigational tools such as; root cause analysis (RCA), 5-why analysis, and/or fishbone diagrams. This role will engage/communicate with all levels of site leadership on the status of all investigations. 


• Execute and document comprehensive non-conformance investigations to include, but not limited, the review of the following cGMP documents: batch records, maintenance work orders, engineering/validation protocols, lab results, and historical review of product specific information maintained within the Quality Management System (QMS). 

• Lead or Participate in Site Investigation Rapid Response team. 

• Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc) partnering with team members to determine 'true' root cause. 

• Conduct personnel interviews of all individuals responsible and/or associated with a non-conforming event. 

• Write a comprehensive, detailed, and accurate event investigation report. The goal is a successful first pass quality review. 

• Write interim reports and extensions for investigations that exceed 30 days. 

• Perform investigations for customer complaints. 

• Write, edit and review plant procedures for accuracy. 

• Perform follow-up activities to coordinate the completion of corrective and/or preventive actions. Perform effectiveness checks for completed corrective actions. 

• Maintain effectiveness of the Quality System components relevant to this position. 

Education: 

• Bachelor's Degree required, preferably in Sciences or Business (e.g., Chemistry/Pharmacy/Engineering/Operations) 

Experience: 

• 10+ years relevant manufacturing/technical experience in a regulated GMP environment; pharma industry preferred 

• 1-3 years relevant technical writing experience 

• Six Sigma or Lean certification a plus 

• Manufacturing quality assurance experience preferred 

• Strong communication/facilitation experience 

• Peer mentoring and developmental leadership
Technical Requirements: 

• Proficient computer skills (e.g., word processing, spreadsheets, database software etc.). MS Office is preferred

• Experience with Trackwise or other quality management investigation software/tools

• Working knowledge of cGMP and safe work practices

• Possess mechanical aptitude and mathematical ability; as well as strong problem solving and analytical skill set

• Proven experience working in a technical writing position

• Possess and demonstrate excellent verbal, written and interpersonal communications skills

• Strong attention to detail

• Skilled at prioritization and multi-tasking
 
 
 
 
 
 
 
 
EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.