Pharmaceutical Quality Specialist - Documentation Specialist

Company: Collabera
Location: Holly Springs
Posted on: April 26, 2025

Job Description:

Responsibilities:

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.


The candidate will be primarily responsible for providing quality oversight of GMP documentation associated with site startup activities. Key responsibilities include reviewing and approving GMP documents, coordinating with site subject matter experts (SMEs) to ensure document adequacy, and communicating progress on actions and deliverables to senior management.

Key Responsibilities:

Ensure timely and accurate review and approval of GMP documents within the applicable GMP systems.


Evaluate documents for compliance with regulatory and procedural requirements, and coordinate with functional SMEs to obtain additional information when necessary.


Complete document approvals within established timelines and communicate status updates and responses to the Senior Manager level.


Collaborate with other departments within to support cross-functional initiatives related to GMP documentation.


Prioritize documentation workflows, maintain a strong understanding of review processes, and ensure adherence to quality standards and timelines.


Perform other duties as assigned by the supervisor.


Pay Range:

$30 - $37 an hr.

Keywords: Collabera, Bartlett , Pharmaceutical Quality Specialist - Documentation Specialist, Healthcare , Holly Springs, Tennessee