QA Controlled Docs Associate

Summary of Responsibilities:

• Follow applicable departmental Standard Operating Procedures and Work Instructions.
• Complete required trainings according to required timelines.
• Administer controlled documents ensuring availability to the end user.
• Track and report metrics as determined by management according to required timelines.
• Ability to participate in process improvement initiatives and assist with implementation of new/revised processes and procedures.
• Ability to train others using developed materials.
• Demonstrated ability to communicate effectively.
• Perform checks to ensure quality of work completed.
• Ensure timely escalation and resolution management of issues impacting controlled document release.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
• Other duties as needed or assigned.

Qualifications (Minimum Required):

• 6 - 8 years in regulatory environment (experience in GXP roles).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Veeva (Quality & Clinical).
• Drafting Change controls and deviations.
• Document management and control.
• Demonstrated ability to plan, prioritize, organize and communicate effectively.
• Demonstrated ability to pay attention to detail.
• Strong interpersonal skills with ability to work well with others.
• Ability to deliver consistent high quality of work.
• Ability to use computer and departmental tools.
• Ability to participate in process improvement initiatives.
• Ability to facilitate meetings.

Physical Demands/Work Environment:

• Tasks involve sitting in front of a terminal for many hours during the working day.

Learn more about our EEO & Accommodations request here .

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.