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QA Technical Writer
Posted date [2012-Feb-07] (ID: 3892)

 

Job Overview: 
 
This position reports to the Quality Assurance Manager. The QA Technical Writer will be responsible for effectively creating technical reports, such as Investigation reports, Deviation reports, Change Controls, Standard Operating Procedures (SOPs) and any other documentation as deemed necessary by QA. Also, the Technical Writer will be ensuring that these reports are written in consultation with the relevant department in accordance with all applicable internal SOPs and industry regulations and guidance. 
 
Job Responsibilities:
Perform investigations and deviations to document non-conformance events to evaluate the strength, identity, safety, purity and quality of the product
Conduct investigations through the use of problem solving tools
Evaluate and recommend appropriate Corrective Actions and Preventative Actions (CAPA) to ensure that potential problems and root causes for deviations and investigations are identified, impact assessed and actions to prevent recurrence are considered and implemented
Ensure communication through extensive interaction with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure accuracy of reports
Provide direct support of all compliance requirements of CGMP standards and FDA regulations involved in the manufacturing processes of a biological product
Work independently to manage reports and ensure adherence to strict deadlines and due dates
Assist the QA Manager in daily operations, as needed
 
 
Additional duties may include:
Write and revise Quality Systems SOPs as necessary to maintain compliance
Author Protocols and/or General Technical Reports
Assist in trending of investigations and deviations
Establish and monitor Quality Assurance programs and procedures to ensure compliance
Training of other employees
 
 
Job Qualifications:
Minimum Bachelor’s of Science degree in a scientific discipline
Experience with documentation and batch record review
3-5 years investigational writing experience in a similar role in the biologics or pharmaceutical industry
Exemplary technical writing skills
Proficient in MS Word
Excellent knowledge of GMPs guidelines, 21 CFR Part 11 and other regulatory standards
Detail oriented
Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills
Ability to diplomatically address sensitive issues confidentially and professionally
Good interpersonal communication skills
Experience in aseptic processing and/or mammalian cell culture production considered a plus

Post Details
Job Title QA Technical Writer
Posted By Ummah Recruiting
Specific Location Exton, PA
Job Function
Start Date 2012-Feb-07
Salary
E-mail
    
    
    
Deadline 2012-Feb-07
    
    
    
    
    
    
    
Category
General Location Location -> USA -> Pennsylvania
Job Type Job Type -> Full-time
Classification Job Classification -> Information Technology