Onsite Senior QA Controlled Docs Coordinator

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About the role

  • QA Controlled Docs Sr. Coordinator ensuring regulatory compliance in document management for Life Sciences. Administering controlled documents and tracking metrics for management.

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.
  • Assist with implementation of new/revised processes and procedures.
  • 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.
  • All other duties as needed or assigned.

Requirements

  • A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
  • 4 to 6 years in regulatory environment (experience in GXP roles).
  • Strong knowledge of QMS, CAPA management, and Veeva Vault.
  • Experience in audit processes is an added advantage.
  • Strong interpersonal skills with ability to work well with others.
  • Demonstrated ability to plan, prioritize, organize and communicate effectively.
  • Demonstrated ability to pay attention to detail.
  • Strong analytical skills.
  • Ability to deliver consistent high quality of work.
  • Ability to use computer and departmental tools.

Benefits

  • Office-based (5 days per week)

Job title

Senior QA Controlled Docs Coordinator

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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